APPLICATION
ANDA089109
TYPE
ANDA
ORIGINAL APPROVAL
1985-09-10
LATEST ACTION
2001-08-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PROMETHAZINE HYDROCHLORIDEDiscontinued
PROMETHAZINE HYDROCHLORIDE 25MG · TABLET · ORAL
Approval history
2001-08-30Manufacturing (CMC) · Supplement 3AP
1988-02-18Manufacturing (CMC) · Supplement 2AP
1985-09-10OriginalAP
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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