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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. One supplier is listed for this compound. Additional details are available on the pentobarbital sodium profile page.

Summary for NDA: 083246

Oak Pharms
pentobarbital sodium

Suppliers and Packaging for NDA: 083246

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
pentobarbital sodium
INJECTABLE;INJECTION 083246 ANDA Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) 76478-501 76478-501-20 1 VIAL in 1 CARTON (76478-501-20) > 20 mL in 1 VIAL
pentobarbital sodium
INJECTABLE;INJECTION 083246 ANDA Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) 76478-501 76478-501-50 1 VIAL in 1 CARTON (76478-501-50) > 50 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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