APPLICATION
ANDA074617
TYPE
ANDA
ORIGINAL APPROVAL
1996-02-28
LATEST ACTION
2001-04-03
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DILTIAZEM HYDROCHLORIDEPrescription
DILTIAZEM HYDROCHLORIDE 5MG/ML · INJECTABLE · INJECTION
Approval history
2001-04-03Manufacturing (CMC) · Supplement 10AP
2000-06-28Manufacturing (CMC) · Supplement 8AP
2000-04-12Labeling · Supplement 9AP
2000-03-30Labeling · Supplement 4AP
2000-03-30Manufacturing (CMC) · Supplement 7AP
2000-03-30Manufacturing (CMC) · Supplement 5AP
2000-03-30Manufacturing (CMC) · Supplement 3AP
2000-03-30Manufacturing (CMC) · Supplement 6AP
1997-04-29Manufacturing (CMC) · Supplement 2AP
1996-09-27Labeling · Supplement 1AP
1996-02-28OriginalAP
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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