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Serving leading biopharmaceutical companies globally:

UBS
McKinsey
Novartis
Fuji
Mallinckrodt
Healthtrust
US Army
Deloitte
Teva
Medtronic

Generated: October 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071428

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NDA 071428 describes TEMAZEPAM, which is a drug marketed by Duramed Pharms Barr, Actavis Elizabeth, Mylan, Sandoz, Watson Labs, Novel Labs Inc, Sun Pharm Inds, Prinston Inc, Amneal Pharms, and Usl Pharma, and is included in nineteen NDAs. It is available from thirty-seven 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. Forty suppliers are listed for this compound. Additional details are available on the temazepam profile page.

Summary for NDA: 071428

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

Pharmacology for NDA: 071428

Ingredient-typeBenzodiazepines

Suppliers and Packaging for NDA: 071428

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEMAZEPAM
temazepam
CAPSULE;ORAL 071428 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7809 0615-7809-39 30 CAPSULE in 1 BLISTER PACK (0615-7809-39)
TEMAZEPAM
temazepam
CAPSULE;ORAL 071428 ANDA Sandoz Inc 0781-2202 0781-2202-01 100 CAPSULE in 1 BOTTLE (0781-2202-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Jan 12, 1988TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Argus Health
Fish and Richardson
US Army
Dow
Daiichi Sankyo
Cerilliant
Citi
McKesson
Queensland Health
Boehringer Ingelheim

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