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Serving leading biopharmaceutical companies globally:

Merck
US Army
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Express Scripts
McKinsey
Novartis
Teva
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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071457

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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 thirty-six 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-nine suppliers are listed for this compound. Additional details are available on the temazepam profile page.

Summary for 071457

Tradename:1
Applicant:1
Ingredient:1
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 0440-8474-05 500 CAPSULE in 1 BOTTLE (0440-8474-05)
TEMAZEPAM temazepam CAPSULE;ORAL 071457 ANDA Liberty Pharmaceuticals, Inc. 0440-8474 0440-8474-01 100 CAPSULE in 1 BOTTLE (0440-8474-01)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Serving leading biopharmaceutical companies globally:

QuintilesIMS
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McKesson
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Dow
Johnson and Johnson

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