Details for New Drug Application (NDA): 204431
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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 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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