APPLICATION
ANDA083312
TYPE
ANDA
ORIGINAL APPROVAL
1973-09-19
LATEST ACTION
2025-06-24
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PROMETHAZINE HYDROCHLORIDE · ReferencePrescription
PROMETHAZINE HYDROCHLORIDE 50MG/ML · INJECTABLE · INJECTION
PROMETHAZINE HYDROCHLORIDE · ReferencePrescription
PROMETHAZINE HYDROCHLORIDE 25MG/ML · INJECTABLE · INJECTION
Approval history
2025-06-24Labeling · Supplement 64 · standardAP
2023-12-27Labeling · Supplement 61 · standardAP
2009-11-19Labeling · Supplement 45AP
2006-03-13Labeling · Supplement 41AP
2005-06-21Labeling · Supplement 38AP
2004-04-19Labeling · Supplement 35AP
2004-04-19Labeling · Supplement 32AP
2002-11-27Manufacturing (CMC) · Supplement 29AP
2002-11-27Labeling · Supplement 30AP
2002-03-12Manufacturing (CMC) · Supplement 28AP
2001-08-09Labeling · Supplement 27AP
1999-11-19Manufacturing (CMC) · Supplement 26AP
1999-02-11Manufacturing (CMC) · Supplement 25AP
1994-12-27Manufacturing (CMC) · Supplement 24AP
1993-06-16Manufacturing (CMC) · Supplement 23AP
1992-10-30Manufacturing (CMC) · Supplement 22AP
1992-03-12Manufacturing (CMC) · Supplement 21AP
1990-11-09Labeling · Supplement 20AP
1990-08-23Labeling · Supplement 19AP
1990-03-30Manufacturing (CMC) · Supplement 18AP
1973-09-19OriginalAP
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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