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Details for New Drug Application (NDA): 205022

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NDA 205022 describes BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Kremers Urban Pharms, Roxane, Ethypharm Usa Corp, Sun Pharm Inds Ltd, Amneal Pharms, and Teva Pharms Usa, and is included in seven NDAs. It is available from thirteen 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-eight drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

Summary for NDA: 205022

Pharmacology for NDA: 205022

Suppliers and Packaging for NDA: 205022

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 205022 ANDA Kremers Urban Pharmaceuticals Inc. 62175-452 62175-452-32 30 TABLET in 1 BOTTLE (62175-452-32)
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL 205022 ANDA Kremers Urban Pharmaceuticals Inc. 62175-458 62175-458-32 30 TABLET in 1 BOTTLE (62175-458-32)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 2MG BASE;EQ 0.5MG BASE
Approval Date:Sep 19, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 8MG BASE;EQ 2MG BASE
Approval Date:Sep 19, 2016TE:ABRLD:No


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