Antidepressant

RegulatoryAugust 5, 2026

FDA Approval Status Update for Sertraline Hydrochloride Supplement

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status of 'AP' for Sertraline Hydrochloride submitted by Heritage Pharma Avet.

RegulatoryJuly 31, 2026

FDA Grants TA for Viloxazine Hydrochloride Application ANDA220326

The FDA has granted Tentative Approval (TA) for Viloxazine Hydrochloride under application ANDA220326 submitted by Appco Pharma LLC.

RegulatoryJuly 31, 2026

FDA Approves Doxepin Hydrochloride Application by Sun Pharma

The FDA has approved the application ANDA213919 for Doxepin Hydrochloride submitted by Sun Pharma.

StrategyJuly 28, 2026

FDA Approves Escitalopram Oxalate Application by Micro Labs

The FDA has approved the ANDA091655 application for Escitalopram Oxalate submitted by Micro Labs.

RegulatoryJuly 24, 2026

FDA Approval Status Update for Doxepin Hydrochloride by Mylan

The FDA has granted an approval status (AP) for the supplemental application ANDA070791 for Doxepin Hydrochloride submitted by Mylan.

RegulatoryJuly 24, 2026

FDA Accepts ANDA for Desvenlafaxine Succinate by Platinum

The FDA has accepted the Abbreviated New Drug Application (ANDA) for Desvenlafaxine Succinate submitted by Platinum.

StrategyJuly 23, 2026

Heritage Pharma's Sertraline Hydrochloride ANDA077345 Receives AP Status

Heritage Pharma's application for Sertraline Hydrochloride has received an Abbreviated Approval (AP) status from the FDA.

StrategyJuly 21, 2026

FDA Grants Abbreviated Approval for Bupropion Hydrochloride by Graviti Pharms

The FDA has granted abbreviated approval for Bupropion Hydrochloride under application ANDA211020 submitted by Graviti Pharms.

StrategyJuly 19, 2026

FDA Grants Approval for Mirtazapine ANDA220104 by Micro Labs

The FDA has granted approval for the ANDA220104 application for Mirtazapine submitted by Micro Labs.

CompetitiveJuly 12, 2026

FDA Approves ANDA for Bupropion Hydrochloride by Yichang Humanwell

The FDA has granted approval for ANDA220529 for Bupropion Hydrochloride submitted by Yichang Humanwell.

RegulatoryJuly 8, 2026

FDA Accepts ANDA for Viloxazine Hydrochloride by Appco Pharma

The FDA has accepted the ANDA for Viloxazine Hydrochloride submitted by Appco Pharma.

StrategyJuly 7, 2026

FDA Grants Approval for Doxepin Hydrochloride ANDA213919 by Sun Pharma

The FDA has granted approval for ANDA213919, a generic version of Doxepin Hydrochloride submitted by Sun Pharma.

StrategyJuly 5, 2026

FDA Approves ANDA for Escitalopram Oxalate by Micro Labs

The FDA has granted approval for ANDA091655, a generic version of Escitalopram Oxalate submitted by Micro Labs.

RegulatoryJuly 3, 2026

Breckenridge's Milnacipran Hydrochloride ANDA205071 Receives AP Status

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status to Breckenridge for Milnacipran Hydrochloride.

RegulatoryJune 23, 2026

FDA Accepts Supplement for Fluoxetine Hydrochloride by Sciegen Pharmaceuticals

The FDA has accepted a supplemental application for Fluoxetine Hydrochloride submitted by Sciegen Pharmaceuticals.

RegulatoryJune 23, 2026

Cadila Pharmaceuticals Issues Class 4 Defect Notification for Mirtazapine 30mg Tablets

Cadila Pharmaceuticals Limited reported a defect in the EAN barcode on Mirtazapine 30mg tablets, affecting distribution.

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