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FDA ANDA · ANDA084554

PROMETHAZINE HYDROCHLORIDE

Sponsor: SUN PHARM INDUSTRIES

APPLICATION
ANDA084554
TYPE
ANDA
ORIGINAL APPROVAL
1975-07-29
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PROMETHAZINE HYDROCHLORIDEDiscontinued
PROMETHAZINE HYDROCHLORIDE 25MG · TABLET · ORAL

Approval history

1998-12-01Manufacturing (CMC) · Supplement 27AP
1994-12-23Manufacturing (CMC) · Supplement 26AP
1994-10-11Manufacturing (CMC) · Supplement 25AP
1992-04-03Manufacturing (CMC) · Supplement 24AP
1992-04-03Manufacturing (CMC) · Supplement 22AP
1987-04-15Manufacturing (CMC) · Supplement 21AP
1975-07-29OriginalAP
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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