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Last Updated: June 12, 2021

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Details for New Drug Application (NDA): 204433

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NDA 204433 describes DIAZEPAM, which is a drug marketed by Lannett Co Inc, Abraxis Pharm, Beloteca Inc, Hospira, Marsam Pharms Llc, Parenta Pharms, Us Army, Warner Chilcott, Watson Labs, Watson Labs Inc, West-ward Pharms Int, Hikma, Actavis Elizabeth, Barr, Dava Pharms Inc, Duramed Pharms Barr, Ferndale Labs, Halsey, Ivax Sub Teva Pharms, Martec Usa Llc, Mayne Pharma, Mylan, Nuvo Pharm, Pioneer Pharms, Roxane, Teva Pharms, Upsher Smith Labs, Vintage Pharms, and Virtus Pharms, and is included in seventy-three NDAs. It is available from thirty-five 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. Thirty-eight suppliers are listed for this compound. Additional details are available on the diazepam profile page.
Summary for 204433
Applicant:Lannett Co Inc
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 204433
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIAZEPAM diazepam CONCENTRATE;ORAL 204433 ANDA Lannett Company, Inc. 0527-1768 0527-1768-36 1 BOTTLE, DROPPER in 1 CARTON (0527-1768-36) > 30 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrength5MG/ML
Approval Date:Apr 14, 2014TE:AARLD:No

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