APPLICATION
ANDA084214
TYPE
ANDA
ORIGINAL APPROVAL
1974-08-14
LATEST ACTION
2001-01-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PROMETHAZINE HYDROCHLORIDEDiscontinued
PROMETHAZINE HYDROCHLORIDE 25MG · TABLET · ORAL
Approval history
2001-01-23Labeling · Supplement 28AP
1997-03-27Labeling · Supplement 32AP
1997-03-27Labeling · Supplement 33AP
1996-05-30Labeling · Supplement 30AP
1991-08-16Labeling · Supplement 29AP
1974-08-14OriginalAP
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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