Details for New Drug Application (NDA): 219850
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NDA 219850 describes BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, which is a drug marketed by Alvogen, Ascent Pharms Inc, Difgen Pharms, Dr Reddys Labs Sa, Mylan Technologies, Actavis Elizabeth, Alkem Labs Ltd, Amneal Pharms, Ethypharm, Hikma, Lannett Co Inc, Rhodes Pharms, Specgx Llc, Sun Pharm, Teva Pharms Usa, and Wes Pharma Inc, and is included in twenty NDAs. It is available from twenty-five 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-seven 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-seven suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
Summary for 219850
| Tradename: | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
| Applicant: | Ascent Pharms Inc |
| Ingredient: | buprenorphine hydrochloride; naloxone hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 219850
| Mechanism of Action | Opioid Antagonists Partial Opioid Agonists |
Suppliers and Packaging for NDA: 219850
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 219850 | ANDA | Camber Pharmaceuticals, Inc. | 31722-479 | 31722-479-30 | 30 POUCH in 1 CARTON (31722-479-30) / 1 FILM, SOLUBLE in 1 POUCH (31722-479-31) |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 219850 | ANDA | Camber Pharmaceuticals, Inc. | 31722-480 | 31722-480-30 | 30 POUCH in 1 CARTON (31722-480-30) / 1 FILM, SOLUBLE in 1 POUCH (31722-480-31) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM;BUCCAL, SUBLINGUAL | Strength | EQ 2MG BASE;EQ 0.5MG BASE | ||||
| Approval Date: | Jan 21, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM;BUCCAL, SUBLINGUAL | Strength | EQ 4MG BASE;EQ 1MG BASE | ||||
| Approval Date: | Jan 21, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM;BUCCAL, SUBLINGUAL | Strength | EQ 8MG BASE;EQ 2MG BASE | ||||
| Approval Date: | Jan 21, 2026 | TE: | AB | RLD: | No | ||||
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