APPLICATION
ANDA083567
TYPE
ANDA
ORIGINAL APPROVAL
1973-10-25
LATEST ACTION
1990-03-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
DIPHENHYDRAMINE HYDROCHLORIDEDiscontinued
DIPHENHYDRAMINE HYDROCHLORIDE 50MG · CAPSULE · ORAL
Approval history
1990-03-01Bioequivalence · Supplement 19AP
1989-05-01Labeling · Supplement 17AP
1986-08-22Manufacturing (CMC) · Supplement 12AP
1973-10-25OriginalAP
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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