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

Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
QuintilesIMS
Express Scripts
Covington
Moodys
Dow
Johnson and Johnson
AstraZeneca
Accenture

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071457

« Back to Dashboard

NDA 071457 describes TEMAZEPAM, which is a drug marketed by Actavis Elizabeth, Amneal Pharms, Duramed Pharms Barr, Mylan, Novel Labs Inc, Prinston Inc, Sandoz, Sun Pharm Industries, Usl Pharma, and Watson Labs, and is included in nineteen NDAs. It is available from twenty-eight suppliers. Additional details are available on the TEMAZEPAM profile page.

The generic ingredient in TEMAZEPAM is temazepam. There are seven drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the temazepam profile page.
Summary for 071457
Tradename:TEMAZEPAM
Applicant:Novel Labs Inc
Ingredient:temazepam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 071457
Ingredient-typeBenzodiazepines
Medical Subject Heading (MeSH) Categories for 071457
Suppliers and Packaging for NDA: 071457
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEMAZEPAM temazepam CAPSULE;ORAL 071457 ANDA Liberty Pharmaceuticals, Inc. 0440-8474 N 0440-8474-01
TEMAZEPAM temazepam CAPSULE;ORAL 071457 ANDA Liberty Pharmaceuticals, Inc. 0440-8474 N 0440-8474-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Apr 21, 1987TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength7.5MG
Approval Date:Jun 22, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength22.5MG
Approval Date:Jun 22, 2012TE:ABRLD:No

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

US Army
Queensland Health
Medtronic
McKesson
Healthtrust
Mallinckrodt
Cantor Fitzgerald
Accenture
Covington

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.