Details for New Drug Application (NDA): 205806
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NDA 205806 describes BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, which is a drug marketed by Alvogen, Difgen Pharms, Dr Reddys Labs Sa, Mylan Technologies, Actavis Elizabeth, Alkem Labs Ltd, Amneal Pharms, Ethypharm Usa Corp, Hikma, Lannett Co Inc, Rhodes Pharms, Specgx Llc, Sun Pharm, Teva Pharms Usa, and Wes Pharma Inc, and is included in eighteen NDAs. It is available from twenty-two suppliers. Additional details are available on the BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE profile page.
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.
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 205806
| Tradename: | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
| Applicant: | Dr Reddys Labs Sa |
| Ingredient: | buprenorphine hydrochloride; naloxone hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 205806
| Mechanism of Action | Opioid Antagonists Partial Opioid Agonists |
Suppliers and Packaging for NDA: 205806
| 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 | 205806 | ANDA | Dr.Reddys Laboratories Inc | 43598-580 | 43598-580-30 | 30 POUCH in 1 CARTON (43598-580-30) / 1 FILM, SOLUBLE in 1 POUCH (43598-580-01) |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 205806 | ANDA | Dr.Reddys Laboratories Inc | 43598-581 | 43598-581-30 | 30 POUCH in 1 CARTON (43598-581-30) / 1 FILM, SOLUBLE in 1 POUCH (43598-581-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM;BUCCAL, SUBLINGUAL | Strength | EQ 4MG BASE;EQ 1MG 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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