Details for New Drug Application (NDA): 207607
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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 207607
Tradename: | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
Applicant: | Mylan Technologies |
Ingredient: | buprenorphine hydrochloride; naloxone hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 207607
Mechanism of Action | Opioid Antagonists Partial Opioid Agonists |
Suppliers and Packaging for NDA: 207607
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 | 207607 | ANDA | Mylan Pharmaceuticals Inc. | 0378-8767 | 0378-8767-93 | 30 POUCH in 1 CARTON (0378-8767-93) / 1 FILM in 1 POUCH (0378-8767-16) |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 207607 | ANDA | Mylan Pharmaceuticals Inc. | 0378-8768 | 0378-8768-93 | 30 POUCH in 1 CARTON (0378-8768-93) / 1 FILM in 1 POUCH (0378-8768-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM;BUCCAL, SUBLINGUAL | Strength | EQ 8MG BASE;EQ 2MG BASE | ||||
Approval Date: | Jun 14, 2018 | 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 14, 2018 | TE: | AB | RLD: | No |
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