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FDA ANDA · ANDA080873

DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE

Sponsor: DR REDDYS

APPLICATION
ANDA080873
TYPE
ANDA
ORIGINAL APPROVAL
1974-01-29
LATEST ACTION
1999-03-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREEDiscontinued
DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML · INJECTABLE · INJECTION
DIPHENHYDRAMINE HYDROCHLORIDEDiscontinued
DIPHENHYDRAMINE HYDROCHLORIDE 10MG/ML · INJECTABLE · INJECTION
DIPHENHYDRAMINE HYDROCHLORIDEDiscontinued
DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML · INJECTABLE · INJECTION

Approval history

1999-03-22Manufacturing (CMC) · Supplement 218AP
1999-02-19Manufacturing (CMC) · Supplement 216AP
1999-02-02Manufacturing (CMC) · Supplement 215AP
1997-01-15Manufacturing (CMC) · Supplement 214AP
1996-08-16Manufacturing (CMC) · Supplement 213AP
1993-11-04Labeling · Supplement 211AP
1989-05-12Labeling · Supplement 206AP
1989-02-11Bioequivalence · Supplement 212AP
1988-12-23Manufacturing (CMC) · Supplement 210AP
1988-01-12Manufacturing (CMC) · Supplement 204AP
1988-01-12Manufacturing (CMC) · Supplement 203AP
1986-10-02Manufacturing (CMC) · Supplement 202AP
1985-07-01Manufacturing (CMC) · Supplement 201AP
1974-01-29OriginalAP
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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