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Details for New Drug Application (NDA): 071756

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NDA 071756 describes OXAZEPAM, which is a drug marketed by Parke Davis, Mylan, Sandoz, Sun Pharm Inds, Ivax Sub Teva Pharms, Actavis Elizabeth, Watson Labs, Am Therap, and Frontida Biopharm, 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: 071756


Pharmacology for NDA: 071756


Suppliers and Packaging for NDA: 071756

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 071756 ANDA Sandoz Inc 0781-2810 0781-2810-01 100 CAPSULE in 1 BOTTLE (0781-2810-01)
CAPSULE;ORAL 071756 ANDA Sandoz Inc 0781-2810 0781-2810-05 500 CAPSULE in 1 BOTTLE (0781-2810-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength15MG
Approval Date:Apr 19, 1988TE:ABRLD:No

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