Details for New Drug Application (NDA): 074617
✉ Email this page to a colleague
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 074617
Tradename: | DILTIAZEM HYDROCHLORIDE |
Applicant: | Sagent |
Ingredient: | diltiazem hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074617
Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors |
Suppliers and Packaging for NDA: 074617
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | INJECTABLE;INJECTION | 074617 | ANDA | Athenex Pharmaceutical Division, LLC. | 70860-301 | 70860-301-05 | 10 VIAL in 1 CARTON (70860-301-05) / 5 mL in 1 VIAL (70860-301-41) |
DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | INJECTABLE;INJECTION | 074617 | ANDA | Athenex Pharmaceutical Division, LLC. | 70860-301 | 70860-301-10 | 10 VIAL in 1 CARTON (70860-301-10) / 10 mL in 1 VIAL (70860-301-42) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/ML | ||||
Approval Date: | Feb 28, 1996 | TE: | AP | RLD: | No |
Complete Access Available with Subscription