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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 078250


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Summary for 078250
Tradename:NAPROXEN
Applicant:Glenmark Generics
Ingredient:naproxen
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078250
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 078250
Suppliers and Packaging for NDA: 078250
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN naproxen TABLET;ORAL 078250 ANDA Medsource Pharmaceuticals 45865-610 45865-610-20 20 TABLET in 1 BOTTLE (45865-610-20)
NAPROXEN naproxen TABLET;ORAL 078250 ANDA A-S Medication Solutions 50090-0481 50090-0481-0 15 TABLET in 1 BOTTLE (50090-0481-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Mar 28, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength375MG
Approval Date:Mar 28, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Mar 28, 2007TE:ABRLD:No

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