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Last Updated: May 25, 2024

Details for New Drug Application (NDA): 010596

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NDA 010596 describes CELONTIN, which is a drug marketed by Parke Davis and is included in one NDA. It is available from one supplier. Additional details are available on the CELONTIN profile page.

The generic ingredient in CELONTIN is methsuximide. Two suppliers are listed for this compound. Additional details are available on the methsuximide profile page.
Summary for 010596
Applicant:Parke Davis
Formulation / Manufacturing:see details
Pharmacology for NDA: 010596
Suppliers and Packaging for NDA: 010596
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CELONTIN methsuximide CAPSULE;ORAL 010596 NDA Parke-Davis Div of Pfizer Inc 0071-0525 0071-0525-24 100 CAPSULE in 1 BOTTLE (0071-0525-24)

Profile for product number 007

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength150MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 008

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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