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FDA ANDA · ANDA203088

DULOXETINE DELAYED-RELEASE

duloxetine hydrochloride

Sponsor: BRECKENRIDGE

APPLICATION
ANDA203088
TYPE
ANDA
ORIGINAL APPROVAL
2014-06-11
LATEST ACTION
2025-03-28
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 40MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
DULOXETINE HYDROCHLORIDEPrescription
DULOXETINE HYDROCHLORIDE EQ 30MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL

Approval history

2025-03-28Labeling · Supplement 28 · standardAP
2025-03-28Labeling · Supplement 26 · standardAP
2018-05-23UNKNOWN · Supplement 7 · standardAP
2015-12-22Manufacturing (CMC) · Supplement 3 · unknownAP
2014-06-11UNKNOWN · Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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