Details for New Drug Application (NDA): 075853
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The generic ingredient in DILTIAZEM HYDROCHLORIDE is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 075853
Tradename: | DILTIAZEM HYDROCHLORIDE |
Applicant: | Hospira |
Ingredient: | diltiazem hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075853
Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors |
Suppliers and Packaging for NDA: 075853
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | INJECTABLE;INJECTION | 075853 | ANDA | Hospira, Inc. | 0409-4350 | 0409-4350-03 | 10 VIAL, PATENT DELIVERY SYSTEM in 1 TRAY (0409-4350-03) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (0409-4350-13) |
DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | INJECTABLE;INJECTION | 075853 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1457 | 51662-1457-1 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (51662-1457-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/VIAL | ||||
Approval Date: | Dec 17, 2002 | TE: | RLD: | No |
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