APPLICATION
ANDA083711
TYPE
ANDA
ORIGINAL APPROVAL
1973-09-21
LATEST ACTION
2005-06-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PROMETHAZINE HYDROCHLORIDEPrescription
PROMETHAZINE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2005-06-09Labeling · Supplement 44AP
2004-12-22Labeling · Supplement 42AP
2001-04-25Manufacturing (CMC) · Supplement 38AP
1997-12-16Manufacturing (CMC) · Supplement 35AP
1997-12-05Manufacturing (CMC) · Supplement 36AP
1991-08-07Manufacturing (CMC) · Supplement 33AP
1991-01-28Manufacturing (CMC) · Supplement 34AP
1990-06-29Manufacturing (CMC) · Supplement 32AP
1989-09-28Labeling · Supplement 63AP
1989-09-28Labeling · Supplement 31AP
1988-03-18Labeling · Supplement 27AP
1986-02-18Manufacturing (CMC) · Supplement 23AP
1986-02-18Manufacturing (CMC) · Supplement 24AP
1983-12-21Manufacturing (CMC) · Supplement 22AP
1973-09-21OriginalAP
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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