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Details for New Drug Application (NDA): 071814

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NDA 071814 describes OXAZEPAM, which is a drug marketed by Parke Davis, Mylan, Sandoz, Frontida Biopharm, Ivax Sub Teva Pharms, Actavis Elizabeth, Watson Labs, Am Therap, and Sun Pharm Inds, 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: 071814

Formulation / Manufacturing:see details

Pharmacology for NDA: 071814


Suppliers and Packaging for NDA: 071814

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 071814 ANDA Sandoz Inc 0781-2811 0781-2811-01 100 CAPSULE in 1 BOTTLE (0781-2811-01)
CAPSULE;ORAL 071814 ANDA Sandoz Inc 0781-2811 0781-2811-05 500 CAPSULE in 1 BOTTLE (0781-2811-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Apr 19, 1988TE:ABRLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.