Details for New Drug Application (NDA): 078538
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The generic ingredient in DILTIAZEM HYDROCHLORIDE is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 078538
Tradename: | DILTIAZEM HYDROCHLORIDE |
Applicant: | West-ward Pharms Int |
Ingredient: | diltiazem hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078538
Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors |
Suppliers and Packaging for NDA: 078538
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | INJECTABLE;INJECTION | 078538 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6013 | 0641-6013-10 | 10 VIAL in 1 CARTON (0641-6013-10) / 5 mL in 1 VIAL (0641-6013-01) |
DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | INJECTABLE;INJECTION | 078538 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6014 | 0641-6014-10 | 10 VIAL in 1 CARTON (0641-6014-10) / 10 mL in 1 VIAL (0641-6014-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/ML | ||||
Approval Date: | Dec 17, 2008 | TE: | AP | RLD: | No |
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