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Last Updated: July 10, 2020

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Details for New Drug Application (NDA): 083246


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NDA 083246 describes NEMBUTAL SODIUM, which is a drug marketed by Oak Pharms and is included in four NDAs. It is available from one supplier. Additional details are available on the NEMBUTAL SODIUM profile page.

The generic ingredient in NEMBUTAL SODIUM is pentobarbital sodium. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the pentobarbital sodium profile page.
Summary for 083246
Tradename:NEMBUTAL SODIUM
Applicant:Oak Pharms
Ingredient:pentobarbital sodium
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 083246
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEMBUTAL SODIUM pentobarbital sodium INJECTABLE;INJECTION 083246 ANDA Akorn, Inc. 17478-181 17478-181-20 1 VIAL, MULTI-DOSE in 1 CARTON (17478-181-20) > 20 mL in 1 VIAL, MULTI-DOSE
NEMBUTAL SODIUM pentobarbital sodium INJECTABLE;INJECTION 083246 ANDA Akorn, Inc. 17478-181 17478-181-50 1 VIAL, MULTI-DOSE in 1 CARTON (17478-181-50) > 50 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Dow
Boehringer Ingelheim
AstraZeneca
Medtronic
Merck

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