Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090622

« Back to Dashboard
NDA 090622 describes BUPRENORPHINE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Ethypharm, Eurohlth Intl Sarl, Luitpold, Roxane, Hospira, Barr, Sun Pharm Inds Ltd, Mylan Pharms Inc, Sandoz Inc, Par Sterile Products, Kremers Urban Pharms, Ethypharm Usa Corp, Amneal Pharms, and Teva Pharms Usa, and is included in eighteen NDAs. It is available from seventeen 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-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

Summary for NDA: 090622

buprenorphine hydrochloride

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
TABLET;SUBLINGUAL 090622 ANDA PD-Rx Pharmaceuticals, Inc. 43063-667 43063-667-06 6 TABLET in 1 BOTTLE, PLASTIC (43063-667-06)
buprenorphine hydrochloride
TABLET;SUBLINGUAL 090622 ANDA A-S Medication Solutions 50090-1571 50090-1571-0 30 TABLET in 1 BOTTLE (50090-1571-0)

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

Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

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.