Impax Labs

RegulatoryAugust 1, 2026

Impax Labs Receives FDA Approval for Metformin Hydrochloride Supplement

Impax Labs has received an Abbreviated New Drug Application (ANDA) approval for a supplement of Metformin Hydrochloride.

RegulatoryAugust 1, 2026

FDA Grants AP Status for Metformin Hydrochloride ANDA076249

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Metformin Hydrochloride submitted by Impax Labs.

RegulatoryJuly 29, 2026

FDA Approval Process Update for Alendronate Sodium by Impax Labs

The FDA has an active application (ANDA075710) for Alendronate Sodium submitted by Impax Labs, currently under standard review.

RegulatoryJuly 28, 2026

Impax Labs receives FDA approval for Methylphenidate Hydrochloride supplement

Impax Labs has received an Abbreviated New Drug Application (ANDA) approval for a supplement related to Methylphenidate Hydrochloride.

RegulatoryJuly 27, 2026

FDA Grants AP Status for Colestipol Hydrochloride Supplement by Impax Labs

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for a supplement of Colestipol Hydrochloride submitted by Impax Labs.

RegulatoryJuly 21, 2026

Impax Labs Receives AP Status for Carbidope and Levodopa Supplement

Impax Labs has received an Abbreviated Approval (AP) for a supplement application of Carbidope and Levodopa.

RegulatoryJuly 5, 2026

Impax Labs Receives AP for Methylphenidate Hydrochloride ANDA205105

Impax Labs has received an Abbreviated Approval (AP) for its ANDA205105 application for Methylphenidate Hydrochloride.

RegulatoryJune 7, 2026

FDA Grants AP Status for Doxycycline Hyclate Supplement by Impax Labs

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for a supplement of Doxycycline Hyclate submitted by Impax Labs.

Recent signals(9)

Impax Labs Receives FDA Approval for Metformin Hydrochloride Supplement

FDA Grants AP Status for Metformin Hydrochloride ANDA076249

FDA Approval Process Update for Alendronate Sodium by Impax Labs

Impax Labs receives FDA approval for Methylphenidate Hydrochloride supplement

FDA Grants AP Status for Colestipol Hydrochloride Supplement by Impax Labs

Impax Labs Receives AP Status for Carbidope and Levodopa Supplement

Impax Labs Receives AP for Methylphenidate Hydrochloride ANDA205105

Impax Labs Receives AP Status for Tetracycline Hydrochloride ANDA060469

FDA Grants AP Status for Doxycycline Hyclate Supplement by Impax Labs

Upcoming catalysts

Regulatory activity(8)

Impax Labs Receives FDA Approval for Metformin Hydrochloride Supplement

FDA Grants AP Status for Metformin Hydrochloride ANDA076249

FDA Approval Process Update for Alendronate Sodium by Impax Labs

Impax Labs receives FDA approval for Methylphenidate Hydrochloride supplement

FDA Grants AP Status for Colestipol Hydrochloride Supplement by Impax Labs

Impax Labs Receives AP Status for Carbidope and Levodopa Supplement

Impax Labs Receives AP for Methylphenidate Hydrochloride ANDA205105

FDA Grants AP Status for Doxycycline Hyclate Supplement by Impax Labs

Clinical activity

Competitive activity

Assets

Therapeutic areas

Indications

Get signals before the market moves