APPLICATION
ANDA080738
TYPE
ANDA
ORIGINAL APPROVAL
1972-08-24
LATEST ACTION
1999-12-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
DIPHENHYDRAMINE HYDROCHLORIDEDiscontinued
DIPHENHYDRAMINE HYDROCHLORIDE 50MG · CAPSULE · ORAL
Approval history
1999-12-21Manufacturing (CMC) · Supplement 88AP
1999-05-21Manufacturing (CMC) · Supplement 84AP
1999-05-20Manufacturing (CMC) · Supplement 85AP
1998-12-01Manufacturing (CMC) · Supplement 83AP
1998-09-08Manufacturing (CMC) · Supplement 82AP
1994-12-23Manufacturing (CMC) · Supplement 81AP
1994-10-11Manufacturing (CMC) · Supplement 80AP
1992-04-03Manufacturing (CMC) · Supplement 79AP
1992-04-03Manufacturing (CMC) · Supplement 77AP
1991-09-13Manufacturing (CMC) · Supplement 76AP
1988-03-10Labeling · Supplement 75AP
1986-04-17Manufacturing (CMC) · Supplement 69AP
1986-03-28Manufacturing (CMC) · Supplement 68AP
1986-03-28Manufacturing (CMC) · Supplement 67AP
1983-03-08Manufacturing (CMC) · Supplement 63AP
1972-08-24OriginalAP
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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