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FDA ANDA · ANDA074894

DILTIAZEM HYDROCHLORIDE

Sponsor: DR REDDYS

APPLICATION
ANDA074894
TYPE
ANDA
ORIGINAL APPROVAL
1997-08-26
LATEST ACTION
2009-03-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 5MG/ML · INJECTABLE · INJECTION

Approval history

2009-03-11Labeling · Supplement 12AP
2002-04-19Manufacturing (CMC) · Supplement 5AP
2002-04-19Manufacturing (CMC) · Supplement 3AP
2002-04-19Labeling · Supplement 1AP
2002-04-19Manufacturing (CMC) · Supplement 6AP
2002-04-19Manufacturing (CMC) · Supplement 4AP
2002-04-19Manufacturing (CMC) · Supplement 2AP
1997-08-26OriginalAP
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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