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FDA ANDA · ANDA090609

ATOMOXETINE

Sponsor: DR REDDYS

APPLICATION
ANDA090609
TYPE
ANDA
ORIGINAL APPROVAL
2018-02-23
LATEST ACTION
2022-05-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ATOMOXETINE HYDROCHLORIDEPrescription
ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE · CAPSULE · ORAL
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

Approval history

2022-05-26Labeling · Supplement 5 · standardAP
2022-05-26Labeling · Supplement 1 · standardAP
2018-02-23OriginalAP
VIEW ON DRUGS@FDA ↗

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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.

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