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Federal Trade Commission
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Harvard Business School
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Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203482

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NDA 203482 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 203482
Tradename:TEMAZEPAM
Applicant:Amneal Pharms
Ingredient:temazepam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203482
Ingredient-typeBenzodiazepines
Medical Subject Heading (MeSH) Categories for 203482
Suppliers and Packaging for NDA: 203482
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEMAZEPAM temazepam CAPSULE;ORAL 203482 ANDA Amneal Pharmaceuticals LLC 65162-556 N 65162-556-03
TEMAZEPAM temazepam CAPSULE;ORAL 203482 ANDA Amneal Pharmaceuticals LLC 65162-556 N 65162-556-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength7.5MG
Approval Date:May 23, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength15MG
Approval Date:May 23, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength22.5MG
Approval Date:May 23, 2016TE:ABRLD:No

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