Details for New Drug Application (NDA): 204431
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NDA 204431 describes BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, which is a drug marketed by Alvogen, Difgen Pharms, Dr Reddys Labs Sa, Mylan Technologies, Actavis Elizabeth, Alkem Labs Ltd, Amneal Pharms, Ethypharm Usa Corp, Hikma, Lannett Co Inc, Rhodes Pharms, Specgx Llc, Sun Pharm, Teva Pharms Usa, and Wes Pharma Inc, and is included in eighteen NDAs. It is available from twenty-two suppliers. Additional details are available on the BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE profile page.
The generic ingredient in BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
The generic ingredient in BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
Summary for 204431
| Tradename: | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
| Applicant: | Ethypharm Usa Corp |
| Ingredient: | buprenorphine hydrochloride; naloxone hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 204431
| Mechanism of Action | Opioid Antagonists Partial Opioid Agonists |
Suppliers and Packaging for NDA: 204431
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204431 | ANDA | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma | 0121-1018 | 0121-1018-30 | 30 TABLET in 1 BOTTLE, PLASTIC (0121-1018-30) |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204431 | ANDA | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma | 0121-2036 | 0121-2036-30 | 30 TABLET in 1 BOTTLE, PLASTIC (0121-2036-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 2MG BASE;EQ 0.5MG BASE | ||||
| Approval Date: | Oct 16, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 8MG BASE;EQ 2MG BASE | ||||
| Approval Date: | Oct 16, 2015 | TE: | AB | RLD: | No | ||||
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