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FDA ANDA · ANDA072416

DIPHENHYDRAMINE HYDROCHLORIDE

Sponsor: SCIEGEN PHARMS

APPLICATION
ANDA072416
TYPE
ANDA
ORIGINAL APPROVAL
1990-09-28
LATEST ACTION
1992-03-18
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

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

Approval history

1992-03-18Manufacturing (CMC) · Supplement 1AP
1992-03-18Manufacturing (CMC) · Supplement 2AP
1992-03-18Labeling · Supplement 3AP
1990-09-28OriginalAP
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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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