DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 076264
NDA 076264 describes NALTREXONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Apotex Inc, Barr, Elite Labs, Fosun Pharma, Specgx Llc, and Sun Pharma Global, 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 076264
| Tradename: | NALTREXONE HYDROCHLORIDE |
| Applicant: | Specgx Llc |
| Ingredient: | naltrexone hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076264
| Mechanism of Action | Opioid Antagonists |
Suppliers and Packaging for NDA: 076264
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NALTREXONE HYDROCHLORIDE | naltrexone hydrochloride | TABLET;ORAL | 076264 | ANDA | SpecGx LLC | 0406-1170 | 0406-1170-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0406-1170-01) |
| NALTREXONE HYDROCHLORIDE | naltrexone hydrochloride | TABLET;ORAL | 076264 | ANDA | SpecGx LLC | 0406-1170 | 0406-1170-03 | 30 TABLET, FILM COATED in 1 BOTTLE (0406-1170-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Mar 22, 2002 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Mar 22, 2002 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Mar 22, 2002 | TE: | RLD: | No | |||||
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