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Details for New Drug Application (NDA): 077069
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NDA 077069 describes AMIODARONE HYDROCHLORIDE, which is a drug marketed by Akorn, Aurobindo Pharma Ltd, Bedford, Bedford Labs, Ben Venue, Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Hospira Inc, Intl Medication Sys, Mylan Institutional, Par Sterile Products, Wockhardt, Mayne Pharma Inc, Murty Pharms, Mylan, Rubicon, Sandoz, Taro, Teva, Teva Pharms, and Zydus Pharms Usa Inc, and is included in twenty-nine NDAs. It is available from twenty-eight suppliers. Additional details are available on the AMIODARONE HYDROCHLORIDE profile page.
The generic ingredient in AMIODARONE HYDROCHLORIDE is amiodarone hydrochloride. There are fifteen drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.
The generic ingredient in AMIODARONE HYDROCHLORIDE is amiodarone hydrochloride. There are fifteen drug master file entries for this compound. Thirty 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 |
| 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 | 42494-307-03 | 30 TABLET in 1 BOTTLE (42494-307-03) |
| AMIODARONE HYDROCHLORIDE | amiodarone hydrochloride | TABLET;ORAL | 077069 | ANDA | Cameron Pharmaceuticals, LLC | 42494-308 | 42494-308-06 | 60 TABLET in 1 BOTTLE (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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