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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070920

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NDA 070920 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-four 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-seven suppliers are listed for this compound. Additional details are available on the temazepam profile page.
Summary for 070920
Tradename:TEMAZEPAM
Applicant:Mylan
Ingredient:temazepam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 070920
Ingredient-typeBenzodiazepines
Medical Subject Heading (MeSH) Categories for 070920
Suppliers and Packaging for NDA: 070920
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEMAZEPAM temazepam CAPSULE;ORAL 070920 ANDA Mylan Pharmaceuticals Inc. 0378-3110 N 0378-3110-01
TEMAZEPAM temazepam CAPSULE;ORAL 070920 ANDA Mylan Pharmaceuticals Inc. 0378-3120 N 0378-3120-93

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Jul 10, 1986TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength7.5MG
Approval Date:May 21, 2010TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength22.5MG
Approval Date:Jun 12, 2009TE:ABRLD:No

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