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FDA ANDA · ANDA213612

PAROXETINE HYDROCHLORIDE

Sponsor: EPIC PHARMA LLC

APPLICATION
ANDA213612
TYPE
ANDA
ORIGINAL APPROVAL
2021-08-11
LATEST ACTION
2022-05-26
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

PAROXETINE HYDROCHLORIDEDiscontinued
PAROXETINE HYDROCHLORIDE EQ 25MG BASE · TABLET, EXTENDED RELEASE · ORAL
PAROXETINE HYDROCHLORIDEDiscontinued
PAROXETINE HYDROCHLORIDE EQ 37.5MG BASE · TABLET, EXTENDED RELEASE · ORAL
PAROXETINE HYDROCHLORIDEDiscontinued
PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2022-05-26Manufacturing (CMC) · Supplement 1 · unknownAP
2021-08-11UNKNOWN · Original · standardAP
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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