Details for New Drug Application (NDA): 076217
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The generic ingredient in AMIODARONE HYDROCHLORIDE is amiodarone hydrochloride. There are fifteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.
Summary for 076217
Tradename: | AMIODARONE HYDROCHLORIDE |
Applicant: | Mylan Institutional |
Ingredient: | amiodarone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 076217
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMIODARONE HYDROCHLORIDE | amiodarone hydrochloride | INJECTABLE;INJECTION | 076217 | ANDA | Henry Schein, Inc | 0404-9815 | 0404-9815-03 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9815-03) / 3 mL in 1 VIAL, SINGLE-DOSE |
AMIODARONE HYDROCHLORIDE | amiodarone hydrochloride | INJECTABLE;INJECTION | 076217 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1358 | 51662-1358-1 | 1 VIAL, GLASS in 1 CARTON (51662-1358-1) / 18 mL in 1 VIAL, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/ML | ||||
Approval Date: | Oct 15, 2002 | TE: | AP | RLD: | No |
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