Details for New Drug Application (NDA): 078578
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NDA 078578 describes AMIODARONE HYDROCHLORIDE, which is a drug marketed by Acella, Bedford, Bedford Labs, Ben Venue, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Intl Medication Sys, Mylan Institutional, Par Sterile Products, Zhejiang Poly Pharm, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys Labs Sa, Norvium Bioscience, Rubicon, Taro, Teva, Teva Pharms, Unichem, Upsher Smith Labs, and Zydus Pharms Usa Inc, and is included in thirty-one NDAs. It is available from thirty-one 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-four 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-four suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.
Summary for 078578
| Tradename: | AMIODARONE HYDROCHLORIDE |
| Applicant: | Rubicon |
| Ingredient: | amiodarone hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 078578
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMIODARONE HYDROCHLORIDE | amiodarone hydrochloride | TABLET;ORAL | 078578 | ANDA | REMEDYREPACK INC. | 70518-3439 | 70518-3439-0 | 30 TABLET in 1 BLISTER PACK (70518-3439-0) |
| AMIODARONE HYDROCHLORIDE | amiodarone hydrochloride | TABLET;ORAL | 078578 | ANDA | REMEDYREPACK INC. | 70518-3439 | 70518-3439-1 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-3439-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Nov 6, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Feb 26, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
| Approval Date: | Feb 26, 2021 | TE: | AB | RLD: | No | ||||
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