Details for New Drug Application (NDA): 079029
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The generic ingredient in AMIODARONE HYDROCHLORIDE is amiodarone hydrochloride. There are fifteen drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.
Summary for 079029
Tradename: | AMIODARONE HYDROCHLORIDE |
Applicant: | Zydus Pharms Usa Inc |
Ingredient: | amiodarone hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 079029
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMIODARONE HYDROCHLORIDE | amiodarone hydrochloride | TABLET;ORAL | 079029 | ANDA | McKesson Corporation dba SKY Packaging | 63739-051 | 63739-051-10 | 10 BLISTER PACK in 1 BOX (63739-051-10) / 10 TABLET in 1 BLISTER PACK |
AMIODARONE HYDROCHLORIDE | amiodarone hydrochloride | TABLET;ORAL | 079029 | ANDA | Zydus Lifesciences Limited | 65841-631 | 65841-631-05 | 500 TABLET in 1 BOTTLE (65841-631-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Sep 16, 2008 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Jan 6, 2023 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
Approval Date: | Jan 6, 2023 | TE: | AB | RLD: | No |
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