DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 076264
The generic ingredient in NALTREXONE HYDROCHLORIDE is naltrexone hydrochloride. There are nineteen drug master file entries for this compound. Fourteen 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 |
Therapeutic Class: | Antidotes, Deterrents, and Toxicologic Agents |
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 | N | 0406-1170-03 |
NALTREXONE HYDROCHLORIDE | naltrexone hydrochloride | TABLET;ORAL | 076264 | ANDA | SpecGx LLC | 0406-1170 | N | 0406-1170-01 |
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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