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Details for New Drug Application (NDA): 072252

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NDA 072252 describes OXAZEPAM, which is a drug marketed by Parke Davis, Mylan, Sandoz, Frontida Biopharm, Ivax Sub Teva Pharms, Actavis Elizabeth, Watson Labs, and Am Therap, and is included in twenty-two NDAs. It is available from eight suppliers. Additional details are available on the OXAZEPAM profile page.

The generic ingredient in OXAZEPAM is oxazepam. There are eight drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the oxazepam profile page.

Summary for NDA: 072252

Tradename:
OXAZEPAM
Applicant:
Actavis Elizabeth
Ingredient:
oxazepam
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 072252

Ingredient-typeBenzodiazepines

Suppliers and Packaging for NDA: 072252

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXAZEPAM
oxazepam
CAPSULE;ORAL 072252 ANDA Actavis Pharma, Inc. 0228-2069 0228-2069-10 100 CAPSULE, GELATIN COATED in 1 BLISTER PACK (0228-2069-10)
OXAZEPAM
oxazepam
CAPSULE;ORAL 072252 ANDA Actavis Pharma, Inc. 0228-2069 0228-2069-50 500 CAPSULE, GELATIN COATED in 1 BOTTLE (0228-2069-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength15MG
Approval Date:Apr 14, 1988TE:ABRLD:No


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