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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 083247


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NDA 083247 describes NEMBUTAL, which is a drug marketed by Akorn, Epic Pharma Llc, and Rising, and is included in six NDAs. Additional details are available on the NEMBUTAL profile page.

The generic ingredient in NEMBUTAL is pentobarbital sodium. There are two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the pentobarbital sodium profile page.
Summary for 083247
Tradename:NEMBUTAL
Applicant:Akorn
Ingredient:pentobarbital sodium
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SUPPOSITORY;RECTALStrength30MG
Approval Date:Jan 25, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SUPPOSITORY;RECTALStrength60MG
Approval Date:Jan 25, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:SUPPOSITORY;RECTALStrength120MG
Approval Date:Jan 25, 1982TE:RLD:No

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