Details for New Drug Application (NDA): 075389
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The generic ingredient in AMIODARONE HYDROCHLORIDE is amiodarone hydrochloride. There are fifteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.
Summary for 075389
Tradename: | AMIODARONE HYDROCHLORIDE |
Applicant: | Dr Reddys Labs Sa |
Ingredient: | amiodarone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 075389
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMIODARONE HYDROCHLORIDE | amiodarone hydrochloride | TABLET;ORAL | 075389 | ANDA | AvKARE | 42291-009 | 42291-009-30 | 30 TABLET in 1 BOTTLE (42291-009-30) |
AMIODARONE HYDROCHLORIDE | amiodarone hydrochloride | TABLET;ORAL | 075389 | ANDA | A-S Medication Solutions | 50090-5062 | 50090-5062-1 | 30 TABLET in 1 BOTTLE (50090-5062-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Jan 25, 2001 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Dec 28, 2017 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
Approval Date: | Dec 28, 2017 | TE: | AB | RLD: | No |
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