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FDA ANDA · ANDA084176

PROMETHAZINE HYDROCHLORIDE

Sponsor: SANDOZ

APPLICATION
ANDA084176
TYPE
ANDA
ORIGINAL APPROVAL
1975-02-18
LATEST ACTION
2009-05-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

PROMETHAZINE HYDROCHLORIDE · ReferencePrescription
PROMETHAZINE HYDROCHLORIDE 25MG · TABLET · ORAL
PROMETHAZINE HYDROCHLORIDE · ReferencePrescription
PROMETHAZINE HYDROCHLORIDE 50MG · TABLET · ORAL
PROMETHAZINE HYDROCHLORIDEDiscontinued
PROMETHAZINE HYDROCHLORIDE 12.5MG · TABLET · ORAL

Approval history

2009-05-22Labeling · Supplement 62AP
2005-06-09Labeling · Supplement 59AP
2004-12-22Labeling · Supplement 57AP
2002-12-16Manufacturing (CMC) · Supplement 54AP
2002-11-20Manufacturing (CMC) · Supplement 52AP
2002-04-19Manufacturing (CMC) · Supplement 53AP
2001-03-23Manufacturing (CMC) · Supplement 51AP
1999-05-05Manufacturing (CMC) · Supplement 50AP
1998-12-15Manufacturing (CMC) · Supplement 49AP
1996-10-03Manufacturing (CMC) · Supplement 48AP
1995-12-01Manufacturing (CMC) · Supplement 47AP
1995-03-17Manufacturing (CMC) · Supplement 46AP
1991-08-28Labeling · Supplement 45AP
1988-11-01Labeling · Supplement 44AP
1986-01-03Manufacturing (CMC) · Supplement 43AP
1985-02-07Manufacturing (CMC) · Supplement 41AP
1983-12-13Manufacturing (CMC) · Supplement 40AP
1983-12-13Manufacturing (CMC) · Supplement 39AP
1983-11-02Manufacturing (CMC) · Supplement 38AP
1983-02-01Manufacturing (CMC) · Supplement 37AP
1982-06-23Manufacturing (CMC) · Supplement 36AP
1982-06-23Manufacturing (CMC) · Supplement 27AP
1982-05-12Manufacturing (CMC) · Supplement 28AP
1982-05-12Manufacturing (CMC) · Supplement 16AP
1982-05-12Manufacturing (CMC) · Supplement 30AP
1982-05-12Manufacturing (CMC) · Supplement 17AP
1982-03-23Manufacturing (CMC) · Supplement 35AP
1981-05-01Manufacturing (CMC) · Supplement 31AP
1975-02-18OriginalAP
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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