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Generated: August 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078633

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NDA 078633 describes BUPRENORPHINE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Ethypharm, Luitpold, West-ward Pharms Int, Hospira, Barr, Sun Pharm Inds Ltd, Mylan Pharms Inc, Rhodes Pharms, Sandoz Inc, Par Sterile Products, Kremers Urban Pharms, Ethypharm Usa Corp, Amneal Pharms, and Teva Pharms Usa, and is included in nineteen NDAs. It is available from eighteen 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-eight drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

Summary for NDA: 078633

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 078633

Mechanism of ActionPartial 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 West-Ward Pharmaceuticals Corp. 0054-0176 0054-0176-13 30 TABLET in 1 BOTTLE (0054-0176-13)
BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochloride
TABLET;SUBLINGUAL 078633 ANDA West-Ward Pharmaceuticals Corp. 0054-0177 0054-0177-13 30 TABLET in 1 BOTTLE (0054-0177-13)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 2MG BASE
Approval Date:Oct 8, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 8MG BASE
Approval Date:Oct 8, 2009TE:ABRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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