APPLICATION
ANDA075086
TYPE
ANDA
ORIGINAL APPROVAL
1998-04-09
LATEST ACTION
2006-07-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DILTIAZEM HYDROCHLORIDEPrescription
DILTIAZEM HYDROCHLORIDE 5MG/ML · INJECTABLE · INJECTION
Approval history
2006-07-17Labeling · Supplement 2AP
2006-07-17Labeling · Supplement 9AP
1998-06-09Labeling · 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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