Details for New Drug Application (NDA): 218473
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NDA 218473 describes BUPRENORPHINE HYDROCHLORIDE, which is a drug marketed by Am Regent, Hikma, Hospira, Ph Health, Somerset Theraps Llc, Actavis Elizabeth, Ascent Pharms Inc, Barr, Ethypharm, Pharmobedient, Rhodes Pharms, Rubicon Research, Specgx Llc, Sun Pharm, Alvogen, Difgen Pharms, Dr Reddys Labs Sa, Mylan Technologies, Alkem Labs Ltd, Amneal Pharms, Lannett Co Inc, Teva Pharms Usa, and Wes Pharma Inc, and is included in thirty-five 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-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 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 218473
| Tradename: | BUPRENORPHINE HYDROCHLORIDE |
| Applicant: | Specgx Llc |
| Ingredient: | buprenorphine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 218473
| Mechanism of Action | Partial Opioid Agonists |
Suppliers and Packaging for NDA: 218473
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE | buprenorphine hydrochloride | TABLET;SUBLINGUAL | 218473 | ANDA | SpecGx LLC | 0406-7012 | 0406-7012-03 | 30 TABLET in 1 BOTTLE (0406-7012-03) |
| BUPRENORPHINE HYDROCHLORIDE | buprenorphine hydrochloride | TABLET;SUBLINGUAL | 218473 | ANDA | SpecGx LLC | 0406-7018 | 0406-7018-03 | 30 TABLET in 1 BOTTLE (0406-7018-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | Dec 10, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 8MG BASE | ||||
| Approval Date: | Dec 10, 2025 | TE: | AB | RLD: | No | ||||
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