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FDA ANDA · ANDA080643

DIPHENHYDRAMINE HYDROCHLORIDE

Sponsor: ROXANE

APPLICATION
ANDA080643
TYPE
ANDA
ORIGINAL APPROVAL
1972-12-20
LATEST ACTION
1999-04-07
ROUTE
ORAL
DOSAGE FORM
ELIXIR
MARKETING STATUS
Discontinued

Products

DIPHENHYDRAMINE HYDROCHLORIDEDiscontinued
DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML · ELIXIR · ORAL

Approval history

1999-04-07Manufacturing (CMC) · Supplement 14AP
1996-08-28Manufacturing (CMC) · Supplement 12AP
1993-11-23Manufacturing (CMC) · Supplement 10AP
1990-12-31Labeling · Supplement 11AP
1988-12-01Manufacturing (CMC) · Supplement 9AP
1988-12-01Manufacturing (CMC) · Supplement 8AP
1972-12-20OriginalAP
VIEW ON DRUGS@FDA ↗

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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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