Details for New Drug Application (NDA): 091205
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NDA 091205 describes NALTREXONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Barr, Chartwell, Elite Labs, Fosun Pharma, Specgx Llc, and Sun Pharm, and is included in seven NDAs. It is available from fifteen suppliers. Additional details are available on the NALTREXONE HYDROCHLORIDE profile page.
The generic ingredient in NALTREXONE HYDROCHLORIDE is naltrexone hydrochloride. There are nineteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the naltrexone hydrochloride profile page.
The generic ingredient in NALTREXONE HYDROCHLORIDE is naltrexone hydrochloride. There are nineteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the naltrexone hydrochloride profile page.
Summary for 091205
| Tradename: | NALTREXONE HYDROCHLORIDE |
| Applicant: | Accord Hlthcare |
| Ingredient: | naltrexone hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 091205
| Mechanism of Action | Opioid Antagonists |
Suppliers and Packaging for NDA: 091205
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NALTREXONE HYDROCHLORIDE | naltrexone hydrochloride | TABLET;ORAL | 091205 | ANDA | Accord Healthcare, Inc. | 16729-081 | 16729-081-01 | 100 TABLET, FILM COATED in 1 BOTTLE (16729-081-01) |
| NALTREXONE HYDROCHLORIDE | naltrexone hydrochloride | TABLET;ORAL | 091205 | ANDA | Accord Healthcare, Inc. | 16729-081 | 16729-081-10 | 30 TABLET, FILM COATED in 1 BOTTLE (16729-081-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Aug 17, 2011 | TE: | AB | RLD: | No | ||||
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