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Last Updated: May 28, 2024

Details for New Drug Application (NDA): 071415

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NDA 071415 describes DIAZEPAM INTENSOL, which is a drug marketed by Hikma and is included in one NDA. It is available from one supplier. Additional details are available on the DIAZEPAM INTENSOL profile page.

The generic ingredient in DIAZEPAM INTENSOL is diazepam. There are eight drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the diazepam profile page.
Summary for 071415
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 071415
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIAZEPAM INTENSOL diazepam CONCENTRATE;ORAL 071415 ANDA Hikma Pharmaceuticals USA Inc. 0054-3185 0054-3185-44 1 BOTTLE in 1 CARTON (0054-3185-44) / 30 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrength5MG/ML
Approval Date:Apr 3, 1987TE:AARLD:No

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