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FDA ANDA · ANDA080949

PROMETHAZINE HYDROCHLORIDE

Sponsor: CHARTWELL MOLECULAR

APPLICATION
ANDA080949
TYPE
ANDA
ORIGINAL APPROVAL
1976-07-28
LATEST ACTION
1992-10-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

1992-10-05Manufacturing (CMC) · Supplement 10AP
1988-07-01Manufacturing (CMC) · Supplement 8AP
1976-07-28OriginalAP
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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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