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FDA ANDA · ANDA090778

DULOXETINE

duloxetine hydrochloride

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA090778
TYPE
ANDA
ORIGINAL APPROVAL
2013-12-11
LATEST ACTION
2023-12-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Prescription

Products

DULOXETINE HYDROCHLORIDEPrescription
DULOXETINE HYDROCHLORIDE EQ 60MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
DULOXETINE HYDROCHLORIDEPrescription
DULOXETINE HYDROCHLORIDE EQ 20MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
DULOXETINE HYDROCHLORIDEPrescription
DULOXETINE HYDROCHLORIDE EQ 30MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL

Approval history

2023-12-19Labeling · Supplement 28 · standardAP
2023-12-19Labeling · Supplement 30 · standardAP
2022-01-25Labeling · Supplement 26 · standardAP
2020-12-16Labeling · Supplement 21 · standardAP
2020-12-16Labeling · Supplement 24 · standardAP
2019-12-13Labeling · Supplement 20 · standardAP
2019-08-19Labeling · Supplement 17 · standardAP
2019-08-19Labeling · Supplement 9 · standardAP
2019-08-19Labeling · Supplement 16 · standardAP
2019-08-19Labeling · Supplement 14 · standardAP
2019-08-19Labeling · Supplement 12 · standardAP
2019-08-19Labeling · Supplement 10 · standardAP
2014-09-26Labeling · Supplement 5 · standardAP
2014-09-26Labeling · Supplement 4 · standardAP
2014-03-20Labeling · Supplement 1 · standardAP
2013-12-11Original — Letter ↗AP
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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