Oral Hypoglycemic — Therapeutic Area Intelligence | Humanexa Signals

RegulatoryAugust 20, 2026

Apotex submits supplemental ANDA for Metformin Hydrochloride

Apotex has submitted a supplemental abbreviated new drug application (ANDA075984) for Metformin Hydrochloride, which is currently under standard review by the FDA.

RegulatoryAugust 20, 2026

FDA grants AP status for Metformin Hydrochloride ANDA076650

The FDA has granted approval status (AP) for ANDA076650, a supplemental application for Metformin Hydrochloride submitted by Pharmobedient.

RegulatoryAugust 20, 2026

FDA Grants Abbreviated Approval for Metformin Hydrochloride by Harman Finochem

The FDA has granted abbreviated approval for Metformin Hydrochloride (ANDA213320) submitted by Harman Finochem.

RegulatoryAugust 19, 2026

ANDA201991 for Metformin Hydrochloride Approved by FDA

The FDA has approved the ANDA201991 application for Metformin Hydrochloride submitted by Inventia, classified under standard review priority.

RegulatoryAugust 19, 2026

FDA Accepts Supplement for RIOMET ER by Sun Pharma

The FDA has accepted the supplemental NDA for RIOMET ER, a metformin hydrochloride formulation, submitted by Sun Pharma.

RegulatoryAugust 19, 2026

Apotex submits supplemental application for Metformin Hydrochloride

Apotex has submitted a supplemental application (ANDA090666) for Metformin Hydrochloride, which is currently under standard review by the FDA. This submission indicates Apotex's strategic intent to enter the diabetes market, where Metformin is a key therapeutic agent.

RegulatoryAugust 19, 2026

FDA Approval Status for Metformin Hydrochloride ANDA076033 by Senores Pharms

The FDA has assigned an Approval Pending (AP) status to ANDA076033 for Metformin Hydrochloride submitted by Senores Pharms.

RegulatoryAugust 19, 2026

Apotex submits supplemental ANDA for Metformin Hydrochloride

Apotex has submitted a supplemental abbreviated new drug application (ANDA076706) for Metformin Hydrochloride, which is currently under standard review by the FDA. This submission adds a new competitor to the existing landscape of generic Metformin products, which are already widely available.

StrategyAugust 18, 2026

FDA Grants Abbreviated Approval for Metformin Hydrochloride by Sciegen Pharmaceuticals

The FDA has granted an abbreviated approval (AP) for the ANDA214629 application for Metformin Hydrochloride submitted by Sciegen Pharmaceuticals.

RegulatoryAugust 18, 2026

FDA Acceptance of Supplement for GLUMETZA by Santarus Inc.

The FDA has accepted a supplemental application for GLUMETZA (metformin hydrochloride) submitted by Santarus Inc.

RegulatoryAugust 18, 2026

Aurobindo Pharma submits SUPPL for Metformin Hydrochloride ANDA079118

Aurobindo Pharma Ltd. has submitted a supplemental application (ANDA079118) for Metformin Hydrochloride, an oral hypoglycemic agent, with a standard review priority by the FDA.

RegulatoryAugust 18, 2026

FDA Grants AP Status for Metformin Hydrochloride ANDA217631 by Laurus

The FDA has granted approval status (AP) for ANDA217631, a supplemental application for Metformin Hydrochloride submitted by Laurus.

RegulatoryAugust 18, 2026

FDA Accepts Supplement Application for Metformin Hydrochloride by CSPC OUYI

The FDA has accepted the supplemental application ANDA205096 for Metformin Hydrochloride submitted by CSPC OUYI.

RegulatoryAugust 18, 2026

FDA Accepts ANDA for Metformin Hydrochloride by Alkem Labs

The FDA has accepted the Abbreviated New Drug Application (ANDA) 206145 for Metformin Hydrochloride submitted by Alkem Labs.

StrategyAugust 18, 2026

Aurobindo Pharma receives AP status for Metformin Hydrochloride ANDA209694

Aurobindo Pharma's ANDA209694 for Metformin Hydrochloride has received Abbreviated Approval (AP) status from the FDA.

RegulatoryAugust 18, 2026

Aurobindo's Metformin Hydrochloride ANDA077095 Receives AP Status from FDA

Aurobindo's ANDA077095 for Metformin Hydrochloride has received Abbreviated Approval (AP) status from the FDA.

RegulatoryAugust 18, 2026

FDA Accepts Supplement for Metformin Hydrochloride by Alkem

The FDA has accepted the supplemental application ANDA091184 for Metformin Hydrochloride submitted by Alkem.

RegulatoryAugust 18, 2026

Teva's Metformin Hydrochloride ANDA Submission Receives AP Status

Teva's Abbreviated Approval (AP) status for Metformin Hydrochloride was granted by the FDA under application ANDA076269, confirming compliance with regulatory standards. This approval allows Teva to enter the diabetes treatment market, which is characterized by significant generic competition.

StrategyAugust 18, 2026

FDA grants AP status for Metformin Hydrochloride ANDA077113

The FDA has granted Abbreviated Approval (AP) status for ANDA077113, a generic application for Metformin Hydrochloride submitted by Pharmobedient.

RegulatoryAugust 18, 2026

FDA grants AP status for Metformin Hydrochloride ANDA078321

The FDA has granted Abbreviated Approval (AP) status to CSPC OUYI for Metformin Hydrochloride under application ANDA078321.

RegulatoryAugust 18, 2026

Harman Finochem's Metformin Hydrochloride ANDA218673 Receives AP Status

The FDA has granted approval status (AP) for Harman Finochem's Abbreviated New Drug Application (ANDA218673) for Metformin Hydrochloride.

RegulatoryAugust 18, 2026

FDA Accepts Supplement for Metformin Hydrochloride by Marksans Pharma

The FDA has accepted the supplemental application ANDA090888 for Metformin Hydrochloride submitted by Marksans Pharma. This application is currently in the standard review priority phase.

RegulatoryAugust 18, 2026

Teva's Metformin Hydrochloride ANDA076864 Receives AP Status

Teva's Abbreviated New Drug Application (ANDA076864) for Metformin Hydrochloride has received an Approved Product (AP) status from the FDA.

RegulatoryAugust 18, 2026

FDA accepts supplemental application for Fortamet (metformin hydrochloride)

The FDA has accepted a supplemental application for Fortamet, a metformin hydrochloride product from Andrx Labs.

StrategyAugust 18, 2026

Sandoz receives AP status for Metformin Hydrochloride ANDA076873

Sandoz's ANDA076873 for Metformin Hydrochloride has received Abbreviated Approval (AP) status from the FDA.

RegulatoryAugust 18, 2026

FDA grants approval for Metformin Hydrochloride ANDA203769 by Sciegen Pharmaceuticals

The FDA has granted approval for the Abbreviated New Drug Application (ANDA203769) for Metformin Hydrochloride submitted by Sciegen Pharmaceuticals.

StrategyAugust 18, 2026

FDA grants AP status for Metformin Hydrochloride ANDA075969

The FDA has granted approval status (AP) for the Abbreviated New Drug Application ANDA075969 for Metformin Hydrochloride submitted by Pharmobedient.

RegulatoryAugust 18, 2026

FDA Approval Status for Metformin Hydrochloride ANDA075965 by Epic Pharma

Epic Pharma LLC has received an Abbreviated New Drug Application (ANDA) approval status for Metformin Hydrochloride under application number ANDA075965.

RegulatoryAugust 18, 2026

FDA Approves Supplement for Metformin Hydrochloride by Sun Pharma

The FDA has approved a supplemental application (ANDA075967) for Metformin Hydrochloride submitted by Sun Pharmaceutical Industries. This approval confirms the safety and efficacy of Sun Pharma's formulation, allowing it to compete more effectively in the diabetes market.

RegulatoryAugust 18, 2026

Marksans Pharma receives AP status for Metformin Hydrochloride ANDA090295

Marksans Pharma has received an Abbreviated New Drug Application (ANDA) approval status for Metformin Hydrochloride under application number ANDA090295.

StrategyAugust 18, 2026

Mylan's Metformin Hydrochloride ANDA075973 Receives AP Status from FDA

The FDA has granted Abbreviated Approval (AP) status to Mylan's ANDA075973 for Metformin Hydrochloride.

RegulatoryAugust 18, 2026

FDA grants AP status to Metformin Hydrochloride ANDA075976

The FDA has granted Abbreviated Approval (AP) status to Pharmobedient's ANDA075976 for Metformin Hydrochloride.

RegulatoryAugust 15, 2026

FDA Acceptance of Supplement for RIOMET ER by Sun Pharma

The FDA has accepted the supplemental NDA for RIOMET ER, a metformin hydrochloride formulation, submitted by Sun Pharma.

RegulatoryAugust 15, 2026

FDA Grants Abbreviated Approval for Metformin Hydrochloride by Macleods

The FDA has granted abbreviated approval for Metformin Hydrochloride under application ANDA206955, submitted by Macleods Pharmaceuticals. This approval allows Macleods to enter the oral hypoglycemic market, where metformin is a standard treatment for type 2 diabetes.

RegulatoryAugust 15, 2026

FDA grants AP status for Metformin Hydrochloride ANDA209882 by Laurus

The FDA has granted Abbreviated Approval (AP) status for ANDA209882, Metformin Hydrochloride application submitted by Laurus.

RegulatoryAugust 15, 2026

Glenmark Pharmaceuticals submits supplemental application for Metformin Hydrochloride

Glenmark Pharmaceuticals has submitted a supplemental application (ANDA078170) for Metformin Hydrochloride, which is currently under standard review by the FDA.

RegulatoryAugust 15, 2026

Ajanta Pharma's Metformin Hydrochloride ANDA213651 Receives AP Status

Ajanta Pharma Ltd. has received Abbreviated New Drug Application (ANDA) approval status for Metformin Hydrochloride under application number ANDA213651.

RegulatoryAugust 15, 2026

Heritage Pharma's Metformin Hydrochloride ANDA075978 Receives AP Status

Heritage Pharma's Abbreviated New Drug Application (ANDA075978) for Metformin Hydrochloride has received an Approval Pending (AP) status from the FDA.

StrategyAugust 15, 2026

FDA Grants Approval for Metformin Hydrochloride ANDA205330

The FDA has granted approval for ANDA205330, a generic version of Metformin Hydrochloride, submitted by AARXION ANDA HLDING. This approval allows AARXION to enter the diabetes treatment market with a product that is expected to compete directly with existing branded Metformin options.

StrategyAugust 15, 2026

Sandoz receives AP status for Metformin Hydrochloride ANDA075985

Sandoz's Abbreviated New Drug Application (ANDA075985) for Metformin Hydrochloride has received Abbreviated Approval (AP) status from the FDA.

RegulatoryAugust 15, 2026

FDA Accepts Supplement for Metformin Hydrochloride by MPP Pharma

The FDA has accepted the supplemental application ANDA203832 for Metformin Hydrochloride submitted by MPP Pharma.

RegulatoryAugust 15, 2026

Unichem's Metformin Hydrochloride ANDA213359 Receives AP Status

Unichem's Abbreviated New Drug Application (ANDA213359) for Metformin Hydrochloride has received an Approval Pending (AP) status from the FDA.

RegulatoryAugust 15, 2026

FDA Grants Abbreviated Approval for Metformin Hydrochloride by Vistapharm

The FDA has granted abbreviated approval for Metformin Hydrochloride under application ANDA212677, submitted by Vistapharm LLC.

RegulatoryAugust 15, 2026

FDA grants AP status for Metformin Hydrochloride ANDA077336 by Sun Pharma

The FDA has granted Abbreviated Approval (AP) status for ANDA077336, a supplemental application for Metformin Hydrochloride submitted by Sun Pharmaceutical Industries.

StrategyAugust 15, 2026

FDA Grants Abbreviated Approval for Metformin Hydrochloride by AlignScience Pharma

The FDA has granted abbreviated approval for Metformin Hydrochloride (ANDA209303) submitted by AlignScience Pharma.

RegulatoryAugust 15, 2026

FDA Grants AP Status for Metformin Hydrochloride ANDA209993 by Qingdao Baheal Pharm

The FDA has granted Abbreviated Approval (AP) status for ANDA209993, a supplemental application for Metformin Hydrochloride submitted by Qingdao Baheal Pharm.

StrategyAugust 15, 2026

FDA grants AP status for Metformin Hydrochloride ANDA209674 by Novast Labs

The FDA has granted Abbreviated Approval (AP) status for Novast Labs' ANDA209674 for Metformin Hydrochloride.

StrategyAugust 15, 2026

FDA Grants Abbreviated Approval for Metformin Hydrochloride by Sunshine

The FDA has granted abbreviated approval (AP) for the ANDA208999 application for Metformin Hydrochloride submitted by Sunshine.

RegulatoryAugust 15, 2026

Bionpharma's Metformin Hydrochloride ANDA219151 Receives AP Status

Bionpharma's Abbreviated New Drug Application (ANDA219151) for Metformin Hydrochloride has received an Approval Pending (AP) status from the FDA.

RegulatoryAugust 15, 2026

FDA grants AP status for Metformin Hydrochloride ANDA208880 by Prinston Inc.

The FDA has granted Abbreviated Approval (AP) status for ANDA208880, Metformin Hydrochloride application submitted by Prinston Inc.

RegulatoryAugust 15, 2026

FDA Accepts Supplement for Metformin Hydrochloride by Saptalis Pharmaceuticals

The FDA has accepted the supplemental application ANDA211309 for Metformin Hydrochloride submitted by Saptalis Pharmaceuticals.

StrategyAugust 15, 2026

Nostrum Pharmaceuticals receives AP status for Metformin Hydrochloride ANDA076756

Nostrum Pharmaceuticals has received an Abbreviated Approval (AP) for ANDA076756, a generic version of Metformin Hydrochloride.

RegulatoryAugust 15, 2026

FDA grants AP status for Metformin Hydrochloride ANDA211052

The FDA has granted approval status (AP) for the Abbreviated New Drug Application ANDA211052 for Metformin Hydrochloride submitted by Yichang Humanwell.

StrategyAugust 14, 2026

FDA grants AP status for Metformin Hydrochloride ANDA077787 by Dr. Reddy's Labs

The FDA has granted Abbreviated Approval (AP) status for Dr. Reddy's Labs' ANDA077787 for Metformin Hydrochloride.

RegulatoryAugust 14, 2026

FDA Accepts Supplement for Metformin Hydrochloride by IPCA Labs

The FDA has accepted the supplemental application ANDA078422 for Metformin Hydrochloride submitted by IPCA Labs.

RegulatoryAugust 14, 2026

Watson Labs receives AP status for Metformin Hydrochloride ANDA076818

Watson Labs Inc. has received Abbreviated Approval (AP) for ANDA076818, a generic version of Metformin Hydrochloride, from the FDA. This approval confirms that Watson Labs has met the necessary regulatory standards for the product, which is positioned within the diabetes treatment market.

RegulatoryAugust 5, 2026

Companies

Assets

Recent signals(81)

Apotex submits supplemental ANDA for Metformin Hydrochloride

FDA grants AP status for Metformin Hydrochloride ANDA076650

FDA Grants Abbreviated Approval for Metformin Hydrochloride by Harman Finochem

ANDA201991 for Metformin Hydrochloride Approved by FDA

FDA Accepts Supplement for RIOMET ER by Sun Pharma

Apotex submits supplemental application for Metformin Hydrochloride

FDA Approval Status for Metformin Hydrochloride ANDA076033 by Senores Pharms

Apotex submits supplemental ANDA for Metformin Hydrochloride

FDA Grants Abbreviated Approval for Metformin Hydrochloride by Sciegen Pharmaceuticals

FDA Acceptance of Supplement for GLUMETZA by Santarus Inc.

Aurobindo Pharma submits SUPPL for Metformin Hydrochloride ANDA079118

FDA Grants AP Status for Metformin Hydrochloride ANDA217631 by Laurus

FDA Accepts Supplement Application for Metformin Hydrochloride by CSPC OUYI

FDA Accepts ANDA for Metformin Hydrochloride by Alkem Labs

Aurobindo Pharma receives AP status for Metformin Hydrochloride ANDA209694

Aurobindo's Metformin Hydrochloride ANDA077095 Receives AP Status from FDA

FDA Accepts Supplement for Metformin Hydrochloride by Alkem

Teva's Metformin Hydrochloride ANDA Submission Receives AP Status

FDA grants AP status for Metformin Hydrochloride ANDA077113

FDA grants AP status for Metformin Hydrochloride ANDA078321

Harman Finochem's Metformin Hydrochloride ANDA218673 Receives AP Status

FDA Accepts Supplement for Metformin Hydrochloride by Marksans Pharma

Teva's Metformin Hydrochloride ANDA076864 Receives AP Status

FDA accepts supplemental application for Fortamet (metformin hydrochloride)

Sandoz receives AP status for Metformin Hydrochloride ANDA076873

FDA grants approval for Metformin Hydrochloride ANDA203769 by Sciegen Pharmaceuticals

FDA grants AP status for Metformin Hydrochloride ANDA075969

FDA Approval Status for Metformin Hydrochloride ANDA075965 by Epic Pharma

FDA Approves Supplement for Metformin Hydrochloride by Sun Pharma

Marksans Pharma receives AP status for Metformin Hydrochloride ANDA090295

Mylan's Metformin Hydrochloride ANDA075973 Receives AP Status from FDA

FDA grants AP status to Metformin Hydrochloride ANDA075976

FDA Acceptance of Supplement for RIOMET ER by Sun Pharma

FDA Grants Abbreviated Approval for Metformin Hydrochloride by Macleods

FDA grants AP status for Metformin Hydrochloride ANDA209882 by Laurus

Glenmark Pharmaceuticals submits supplemental application for Metformin Hydrochloride

Ajanta Pharma's Metformin Hydrochloride ANDA213651 Receives AP Status

Heritage Pharma's Metformin Hydrochloride ANDA075978 Receives AP Status

FDA Grants Approval for Metformin Hydrochloride ANDA205330

Sandoz receives AP status for Metformin Hydrochloride ANDA075985

FDA Accepts Supplement for Metformin Hydrochloride by MPP Pharma

Unichem's Metformin Hydrochloride ANDA213359 Receives AP Status

FDA Grants Abbreviated Approval for Metformin Hydrochloride by Vistapharm

FDA grants AP status for Metformin Hydrochloride ANDA077336 by Sun Pharma

FDA Grants Abbreviated Approval for Metformin Hydrochloride by AlignScience Pharma

FDA Grants AP Status for Metformin Hydrochloride ANDA209993 by Qingdao Baheal Pharm

FDA grants AP status for Metformin Hydrochloride ANDA209674 by Novast Labs

FDA Grants Abbreviated Approval for Metformin Hydrochloride by Sunshine

Bionpharma's Metformin Hydrochloride ANDA219151 Receives AP Status

FDA grants AP status for Metformin Hydrochloride ANDA208880 by Prinston Inc.

FDA Accepts Supplement for Metformin Hydrochloride by Saptalis Pharmaceuticals

Nostrum Pharmaceuticals receives AP status for Metformin Hydrochloride ANDA076756

FDA grants AP status for Metformin Hydrochloride ANDA211052

FDA grants AP status for Metformin Hydrochloride ANDA077787 by Dr. Reddy's Labs

FDA Accepts Supplement for Metformin Hydrochloride by IPCA Labs

Watson Labs receives AP status for Metformin Hydrochloride ANDA076818

FDA Grants Abbreviated Approval for Metformin Hydrochloride by Amneal Pharmaceuticals

FDA Grants Approval for Metformin Hydrochloride ANDA077124

FDA Accepts Supplement for Metformin Hydrochloride by Sun Pharma

Impax Labs Receives FDA Approval for Metformin Hydrochloride Supplement

FDA Grants AP Status for Metformin Hydrochloride ANDA209313 by Granules

FDA Grants AP Status for Metformin Hydrochloride ANDA076249

FDA Grants Approval for Metformin Hydrochloride ANDA207427

FDA Grants AP Status for Metformin Hydrochloride ANDA202306

FDA Approves Metformin Hydrochloride ANDA077064 by Zydus Pharms USA

FDA Accepts Supplement for Metformin Hydrochloride by Amneal Pharmaceuticals

Lupin's Metformin Hydrochloride ANDA090692 Receives AP Status from FDA

Torrent Pharmaceuticals receives AP status for Metformin Hydrochloride ANDA079226

Torrent's Metformin Hydrochloride ANDA090014 Receives AP Status

FDA Grants Approval for Metformin Hydrochloride ANDA077060 by Zydus Lifesciences

FDA Grants Approval for Zydus Lifesciences' Metformin Hydrochloride ANDA077078

FDA Grants Abbreviated Approval for Metformin Hydrochloride by Actavis Elizabeth

Torrent Pharmaceuticals receives AP status for Metformin Hydrochloride ANDA077711

FDA Approves Metformin Hydrochloride ANDA075961 from Watson Labs

FDA Grants Approval for Watson Labs' Metformin Hydrochloride Supplement

FDA Accepts Supplement for Metformin Hydrochloride by Actavis Elizabeth

Sandoz Receives FDA Approval for Metformin Hydrochloride Supplement