Details for New Drug Application (NDA): 211586
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NDA 211586 describes BUPRENORPHINE, which is a drug marketed by Alvogen, Amneal, Difgen Pharms, Mylan Tech Viatris, Watson Labs Teva, Am Regent, Endo Operations, Hikma, Hospira, Actavis Elizabeth, Barr, Ethypharm, Norvium Bioscience, Rhodes Pharms, Rubicon, Sun Pharm, 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-six NDAs. It is available from five suppliers. Additional details are available on the BUPRENORPHINE profile page.
The generic ingredient in BUPRENORPHINE 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 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 211586
| Tradename: | BUPRENORPHINE |
| Applicant: | Amneal |
| Ingredient: | buprenorphine |
| Patents: | 0 |
Pharmacology for NDA: 211586
| Mechanism of Action | Partial Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 211586
Suppliers and Packaging for NDA: 211586
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUPRENORPHINE | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 211586 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1202 | 69238-1202-2 | 4 POUCH in 1 CARTON (69238-1202-2) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH |
| BUPRENORPHINE | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 211586 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1203 | 69238-1203-2 | 4 POUCH in 1 CARTON (69238-1203-2) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 5MCG/HR | ||||
| Approval Date: | Apr 14, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 7.5MCG/HR | ||||
| Approval Date: | Apr 14, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 10MCG/HR | ||||
| Approval Date: | Apr 14, 2020 | TE: | AB | RLD: | No | ||||
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