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Generated: August 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071620

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NDA 071620 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-five 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-eight suppliers are listed for this compound. Additional details are available on the temazepam profile page.

Summary for NDA: 071620

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

Pharmacology for NDA: 071620

Ingredient-typeBenzodiazepines

Suppliers and Packaging for NDA: 071620

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEMAZEPAM
temazepam
CAPSULE;ORAL 071620 ANDA Actavis Pharma, Inc. 0228-2076 0228-2076-10 100 CAPSULE in 1 BOTTLE (0228-2076-10)
TEMAZEPAM
temazepam
CAPSULE;ORAL 071620 ANDA Actavis Pharma, Inc. 0228-2076 0228-2076-50 500 CAPSULE in 1 BOTTLE (0228-2076-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Aug 7, 1987TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength15MG
Approval Date:Aug 7, 1987TE:ABRLD:No


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Fish and Richardson
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