APPLICATION
ANDA084233
TYPE
ANDA
LATEST ACTION
1985-02-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PROMETHAZINE HYDROCHLORIDEDiscontinued
PROMETHAZINE HYDROCHLORIDE 12.5MG · TABLET · ORAL
Approval history
1985-02-08Manufacturing (CMC) · Supplement 8AP
1983-08-17Manufacturing (CMC) · Supplement 6AP
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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