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Details for New Drug Application (NDA): 077069
The generic ingredient in AMIODARONE HYDROCHLORIDE is amiodarone hydrochloride. There are fifteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.
Summary for 077069
Tradename: | AMIODARONE HYDROCHLORIDE |
Applicant: | Murty Pharms |
Ingredient: | amiodarone hydrochloride |
Patents: | 0 |
Therapeutic Class: | Cardiovascular Agents |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 077069
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMIODARONE HYDROCHLORIDE | amiodarone hydrochloride | TABLET;ORAL | 077069 | ANDA | Cameron Pharmaceuticals, LLC | 42494-307 | N | 42494-307-03 |
AMIODARONE HYDROCHLORIDE | amiodarone hydrochloride | TABLET;ORAL | 077069 | ANDA | Cameron Pharmaceuticals, LLC | 42494-308 | N | 42494-308-06 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Apr 8, 2005 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
Approval Date: | Apr 8, 2005 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Oct 4, 2016 | TE: | AB | RLD: | No |
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