APPLICATION
ANDA080629
TYPE
ANDA
ORIGINAL APPROVAL
1974-01-29
LATEST ACTION
2004-09-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PROMETHAZINE HYDROCHLORIDEDiscontinued
PROMETHAZINE HYDROCHLORIDE 50MG/ML · INJECTABLE · INJECTION
Approval history
2004-09-27Labeling · Supplement 218AP
2003-06-09Labeling · Supplement 215AP
2002-11-20Manufacturing (CMC) · Supplement 210AP
1999-02-19Manufacturing (CMC) · Supplement 208AP
1999-02-02Manufacturing (CMC) · Supplement 207AP
1996-12-04Manufacturing (CMC) · Supplement 206AP
1992-05-06Manufacturing (CMC) · Supplement 205AP
1991-01-11Labeling · Supplement 204AP
1990-04-09Labeling · Supplement 203AP
1989-10-12Labeling · Supplement 202AP
1989-10-12Labeling · Supplement 201AP
1989-04-11Manufacturing (CMC) · Supplement 200AP
1989-04-11Manufacturing (CMC) · Supplement 199AP
1988-08-03Manufacturing (CMC) · Supplement 196AP
1988-08-03Manufacturing (CMC) · Supplement 195AP
1986-06-16Manufacturing (CMC) · Supplement 191AP
1982-11-03Manufacturing (CMC) · Supplement 187AP
1982-04-23Manufacturing (CMC) · Supplement 184AP
1982-04-23Manufacturing (CMC) · Supplement 155AP
1974-01-29OriginalAP
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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