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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 071135


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NDA 071135 describes DIAZEPAM, which is a drug marketed by Chartwell Molecular, Novel Labs Inc, Abraxis Pharm, Beloteca, Fresenius Kabi Usa, Hikma, Hospira, Marsam Pharms Llc, Parenta Pharms, Us Army, Warner Chilcott, Watson Labs, Watson Labs Inc, Actavis Elizabeth, Aurobindo Pharma Ltd, Barr, Chartwell Rx, Dava Pharms Inc, Dr Reddys Labs Sa, Duramed Pharms Barr, Ferndale Labs, Halsey, Ivax Sub Teva Pharms, Martec Usa Llc, Mylan, Nuvo Pharm, Pioneer Pharms, Roxane, Strides Pharma, Teva Pharms, and Virtus, and is included in seventy-six NDAs. It is available from thirty-seven suppliers. Additional details are available on the DIAZEPAM profile page.

The generic ingredient in DIAZEPAM is diazepam. There are eight drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the diazepam profile page.
Summary for 071135
Tradename:DIAZEPAM
Applicant:Dr Reddys Labs Sa
Ingredient:diazepam
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 071135
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIAZEPAM diazepam TABLET;ORAL 071135 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-278 43353-278-15 15 TABLET in 1 BOTTLE, PLASTIC (43353-278-15)
DIAZEPAM diazepam TABLET;ORAL 071135 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-278 43353-278-20 20 TABLET in 1 BOTTLE, PLASTIC (43353-278-20)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 3, 1987TE:ABRLD:No

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