Details for New Drug Application (NDA): 212756
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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 212756
Tradename: | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
Applicant: | Difgen Pharms |
Ingredient: | buprenorphine hydrochloride; naloxone hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 212756
Mechanism of Action | Opioid Antagonists Partial Opioid Agonists |
Suppliers and Packaging for NDA: 212756
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 | 212756 | ANDA | INGENUS PHARMACEUTICALS, LLC | 50742-364 | 50742-364-30 | 30 POUCH in 1 CARTON (50742-364-30) / 1 FILM in 1 POUCH (50742-364-01) |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 212756 | ANDA | INGENUS PHARMACEUTICALS, LLC | 50742-365 | 50742-365-30 | 30 POUCH in 1 CARTON (50742-365-30) / 1 FILM in 1 POUCH (50742-365-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM;BUCCAL, SUBLINGUAL | Strength | EQ 8MG BASE;EQ 2MG BASE | ||||
Approval Date: | Jun 2, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM;BUCCAL, SUBLINGUAL | Strength | EQ 12MG BASE;EQ 3MG BASE | ||||
Approval Date: | Jun 2, 2022 | TE: | AB | RLD: | No |
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