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FDA ANDA · ANDA085083

DIPHENHYDRAMINE HYDROCHLORIDE

Sponsor: WATSON LABS

APPLICATION
ANDA085083
TYPE
ANDA
ORIGINAL APPROVAL
1976-06-29
LATEST ACTION
1998-07-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

DIPHENHYDRAMINE HYDROCHLORIDEDiscontinued
DIPHENHYDRAMINE HYDROCHLORIDE 50MG · CAPSULE · ORAL

Approval history

1998-07-17Manufacturing (CMC) · Supplement 35AP
1997-05-23Manufacturing (CMC) · Supplement 34AP
1991-04-02Labeling · Supplement 33AP
1990-08-31Labeling · Supplement 32AP
1988-12-21Manufacturing (CMC) · Supplement 30AP
1988-12-21Manufacturing (CMC) · Supplement 29AP
1988-12-21Manufacturing (CMC) · Supplement 31AP
1986-12-03Manufacturing (CMC) · Supplement 24AP
1986-12-03Manufacturing (CMC) · Supplement 25AP
1986-12-03Manufacturing (CMC) · Supplement 23AP
1986-04-14Manufacturing (CMC) · Supplement 26AP
1983-11-16Manufacturing (CMC) · Supplement 20AP
1983-04-25Manufacturing (CMC) · Supplement 18AP
1983-04-25Manufacturing (CMC) · Supplement 16AP
1983-04-25Manufacturing (CMC) · Supplement 14AP
1983-04-25Manufacturing (CMC) · Supplement 17AP
1983-04-25Manufacturing (CMC) · Supplement 15AP
1976-06-29OriginalAP
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