Anticonvulsant

StrategyAugust 5, 2026

Teva's Gabapentin ANDA075435 Receives AP Status from FDA

Teva Pharmaceuticals has received an Abbreviated New Drug Application (ANDA) approval status for Gabapentin.

RegulatoryAugust 3, 2026

FDA Grants Approval for Gabapentin Supplement by Zhejiang Yongtai

The FDA has granted approval for a supplemental application for Gabapentin submitted by Zhejiang Yongtai.

StrategyAugust 3, 2026

Teva's Gabapentin ANDA205807 Receives AP Status from FDA

Teva Pharmaceuticals has received an Abbreviated New Drug Application (ANDA) approval for Gabapentin.

RegulatoryJuly 31, 2026

FDA Approval Process Update for Gabapentin ANDA214957

The FDA is reviewing ANDA214957 for Gabapentin submitted by Ascent Pharms Inc. under standard review priority.

StrategyJuly 29, 2026

FDA Grants Approval for Gabapentin ANDA214956 by Ascent Pharm Inc.

The FDA has granted approval for ANDA214956, a supplemental application for Gabapentin submitted by Ascent Pharm Inc.

StrategyJuly 29, 2026

FDA Grants AP Status for Topiramate ANDA079162 by Invagen Pharmaceuticals

The FDA has granted Abbreviated Approval (AP) status for the ANDA079162 application for Topiramate submitted by Invagen Pharmaceuticals.

RegulatoryJuly 27, 2026

FDA Approves Supplement for Valproic Acid by Quagen

The FDA has approved a supplemental application for Valproic Acid submitted by Quagen.

RegulatoryJuly 25, 2026

FDA Grants AP Status for Gabapentin ANDA217995 by Rising

The FDA has granted approval status (AP) for ANDA217995, a supplemental application for Gabapentin submitted by Rising.

RegulatoryJuly 25, 2026

FDA Accepts Supplement Application for Gabapentin by Zydus Pharmaceuticals

The FDA has accepted a supplemental application for gabapentin submitted by Zydus Pharmaceuticals.

StrategyJuly 23, 2026

Sandoz's Gabapentin ANDA075428 Receives Abbreviated Approval

Sandoz has received an abbreviated approval for its ANDA075428 application for Gabapentin.

StrategyJuly 19, 2026

FDA Approves Clonazepam ANDA216988 from Rubicon Research

The FDA has approved ANDA216988 for Clonazepam submitted by Rubicon Research.

RegulatoryJuly 13, 2026

Teva Pharmaceuticals Receives AP Status for Gabapentin Supplement

Teva Pharmaceuticals has received an Abbreviated Approval (AP) for a supplemental application for Gabapentin.

RegulatoryJuly 12, 2026

Teva's Gabapentin ANDA205807 Receives Approval Status from FDA

Teva Pharmaceuticals USA has received an approval status (AP) for its Abbreviated New Drug Application (ANDA205807) for Gabapentin.

RegulatoryJuly 11, 2026

FDA Grants AP Status for Gabapentin ANDA213603 by Zhejiang Yongtai

The FDA has granted approval status (AP) for the ANDA213603 application for Gabapentin submitted by Zhejiang Yongtai.

RegulatoryJuly 7, 2026

FDA Grants AP Status for Gabapentin ANDA214957 by Ascent Pharm

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for gabapentin submitted by Ascent Pharm.

RegulatoryJuly 6, 2026

FDA Grants Abbreviated Approval for Gabapentin by Ascent Pharmaceuticals

The FDA has granted an abbreviated approval for Gabapentin under application ANDA214956 submitted by Ascent Pharmaceuticals.

RegulatoryJuly 1, 2026

FDA Grants AP Status for Gabapentin ANDA077661 by Rubicon Research

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Gabapentin submitted by Rubicon Research.

RegulatoryJuly 1, 2026

FDA Grants AP Status for Valproic Acid ANDA073229 by Catalent

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Valproic Acid submitted by Catalent.

StrategyJune 27, 2026

FDA Grants Approval for Gabapentin ANDA203611 by Actavis Elizabeth

The FDA has granted approval for ANDA203611, a generic version of Gabapentin submitted by Actavis Elizabeth.

RegulatoryJune 18, 2026

TARO's ANDA219052 for PERAMPANEL Receives Approval Status

TARO's ANDA219052 for PERAMPANEL has received an approval status (AP) from the FDA.