Details for New Drug Application (NDA): 204742
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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 204742
Tradename: | AMIODARONE HYDROCHLORIDE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | amiodarone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 204742
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMIODARONE HYDROCHLORIDE | amiodarone hydrochloride | TABLET;ORAL | 204742 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8258 | 0615-8258-05 | 15 TABLET in 1 BLISTER PACK (0615-8258-05) |
AMIODARONE HYDROCHLORIDE | amiodarone hydrochloride | TABLET;ORAL | 204742 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8258 | 0615-8258-39 | 30 TABLET in 1 BLISTER PACK (0615-8258-39) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Jun 3, 2016 | TE: | AB | RLD: | No |
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