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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
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Generated: August 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090622

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NDA 090622 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: 090622

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

Pharmacology for NDA: 090622

Mechanism of ActionPartial Opioid Agonists

Suppliers and Packaging for NDA: 090622

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochloride
TABLET;SUBLINGUAL 090622 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-556 35356-556-30 30 TABLET in 1 BOTTLE (35356-556-30)
BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochloride
TABLET;SUBLINGUAL 090622 ANDA PD-Rx Pharmaceuticals, Inc. 43063-667 43063-667-06 6 TABLET in 1 BOTTLE, PLASTIC (43063-667-06)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 2MG BASE
Approval Date:Sep 24, 2010TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 8MG BASE
Approval Date:Sep 24, 2010TE:ABRLD:No


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QuintilesIMS
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