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FDA ANDA · ANDA072577

PRAZOSIN HYDROCHLORIDE

Sponsor: ANI PHARMS

APPLICATION
ANDA072577
TYPE
ANDA
ORIGINAL APPROVAL
1989-04-10
LATEST ACTION
1994-01-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

PRAZOSIN HYDROCHLORIDEDiscontinued
PRAZOSIN HYDROCHLORIDE EQ 1MG BASE · CAPSULE · ORAL
PRAZOSIN HYDROCHLORIDEDiscontinued
PRAZOSIN HYDROCHLORIDE EQ 5MG BASE · CAPSULE · ORAL
PRAZOSIN HYDROCHLORIDEDiscontinued
PRAZOSIN HYDROCHLORIDE EQ 2MG BASE · CAPSULE · ORAL

Approval history

1994-01-24Manufacturing (CMC) · Supplement 6AP
1990-06-04Labeling · Supplement 4AP
1989-04-10OriginalAP
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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