APPLICATION
ANDA074941
TYPE
ANDA
ORIGINAL APPROVAL
1998-04-15
LATEST ACTION
2017-12-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 5MG/ML · INJECTABLE · INJECTION
Approval history
2017-12-13Labeling · Supplement 9 · standardAP
2006-12-22Labeling · Supplement 6AP
2001-02-14Manufacturing (CMC) · Supplement 2AP
2000-05-12Manufacturing (CMC) · Supplement 1AP
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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