Details for New Drug Application (NDA): 078633
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NDA 078633 describes BUPRENORPHINE HYDROCHLORIDE, which is a drug marketed by Alvogen, Am Regent, Endo Operations, Hikma, Hospira, Actavis Elizabeth, Barr, Ethypharm, Norvium Bioscience, Rhodes Pharms, Rubicon, Sun Pharm, Difgen Pharms, Dr Reddys Labs Sa, Mylan Technologies, Alkem Labs Ltd, Amneal Pharms, Ethypharm Usa Corp, Lannett Co Inc, Specgx Llc, Teva Pharms Usa, and Wes Pharma Inc, and is included in thirty-one NDAs. It is available from twenty suppliers. Additional details are available on the BUPRENORPHINE HYDROCHLORIDE profile page.
The generic ingredient in BUPRENORPHINE 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 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 078633
| Tradename: | BUPRENORPHINE HYDROCHLORIDE |
| Applicant: | Hikma |
| Ingredient: | buprenorphine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078633
| Mechanism of Action | Partial Opioid Agonists |
Suppliers and Packaging for NDA: 078633
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE | buprenorphine hydrochloride | TABLET;SUBLINGUAL | 078633 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0176 | 0054-0176-13 | 30 TABLET in 1 BOTTLE (0054-0176-13) |
| BUPRENORPHINE HYDROCHLORIDE | buprenorphine hydrochloride | TABLET;SUBLINGUAL | 078633 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0177 | 0054-0177-13 | 30 TABLET in 1 BOTTLE (0054-0177-13) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | Oct 8, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 8MG BASE | ||||
| Approval Date: | Oct 8, 2009 | TE: | AB | RLD: | No | ||||
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