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FDA ANDA · ANDA088864

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA088864
TYPE
ANDA
ORIGINAL APPROVAL
1985-01-04
LATEST ACTION
2006-06-07
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription

Products

PROMETHAZINE W/ DEXTROMETHORPHANPrescription
DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML, PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML · SYRUP · ORAL

Approval history

2006-06-07Labeling · Supplement 27AP
1997-07-09Manufacturing (CMC) · Supplement 18AP
1997-07-09Manufacturing (CMC) · Supplement 22AP
1997-07-09Manufacturing (CMC) · Supplement 20AP
1997-07-09Manufacturing (CMC) · Supplement 19AP
1997-07-09Labeling · Supplement 23AP
1997-07-09Manufacturing (CMC) · Supplement 21AP
1991-10-18Labeling · Supplement 16AP
1990-08-24Labeling · Supplement 15AP
1989-06-19Labeling · Supplement 14AP
1989-04-05Manufacturing (CMC) · Supplement 13AP
1988-08-16Manufacturing (CMC) · Supplement 12AP
1987-04-07Manufacturing (CMC) · Supplement 6AP
1987-04-07Manufacturing (CMC) · Supplement 4AP
1987-04-07Manufacturing (CMC) · Supplement 7AP
1987-04-07Manufacturing (CMC) · Supplement 5AP
1987-04-07Manufacturing (CMC) · Supplement 3AP
1986-06-26Manufacturing (CMC) · Supplement 2AP
1986-03-06Manufacturing (CMC) · Supplement 1AP
1985-01-04OriginalAP
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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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