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FDA ANDA · ANDA088896

PROMETHAZINE VC W/ CODEINE

Sponsor: WOCKHARDT

APPLICATION
ANDA088896
TYPE
ANDA
ORIGINAL APPROVAL
1985-01-04
LATEST ACTION
1990-08-23
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

PROMETHAZINE VC W/ CODEINEDiscontinued
CODEINE PHOSPHATE 10MG/5ML, PHENYLEPHRINE HYDROCHLORIDE 5MG/5ML, PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML · SYRUP · ORAL

Approval history

1990-08-23Labeling · Supplement 15AP
1989-05-22Labeling · Supplement 14AP
1988-08-16Manufacturing (CMC) · Supplement 12AP
1987-04-07Manufacturing (CMC) · Supplement 7AP
1987-04-07Manufacturing (CMC) · Supplement 5AP
1987-04-07Manufacturing (CMC) · Supplement 8AP
1987-04-07Manufacturing (CMC) · Supplement 6AP
1987-04-07Manufacturing (CMC) · Supplement 4AP
1986-06-02Manufacturing (CMC) · Supplement 3AP
1986-03-06Manufacturing (CMC) · Supplement 1AP
1986-03-06Manufacturing (CMC) · Supplement 2AP
1985-01-04OriginalAP
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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