← FDA DRUG APPROVALS

FDA ANDA · ANDA079021

ATOMOXETINE

Sponsor: STRIDES PHARMA

APPLICATION
ANDA079021
TYPE
ANDA
ORIGINAL APPROVAL
2021-02-18
LATEST ACTION
2023-02-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ATOMOXETINE HYDROCHLORIDEPrescription
ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE · CAPSULE · ORAL
ATOMOXETINE HYDROCHLORIDEPrescription
ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE · CAPSULE · ORAL
ATOMOXETINE HYDROCHLORIDEPrescription
ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE · CAPSULE · ORAL
ATOMOXETINE HYDROCHLORIDEPrescription
ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL
ATOMOXETINE HYDROCHLORIDEPrescription
ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE · CAPSULE · ORAL
ATOMOXETINE HYDROCHLORIDEPrescription
ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE · CAPSULE · ORAL
ATOMOXETINE HYDROCHLORIDEPrescription
ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE · CAPSULE · ORAL

Approval history

2023-02-15Labeling · Supplement 4 · standardAP
2021-02-18OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →