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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 218497


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Summary for 218497
Tradename:NAPROXEN
Applicant:Novitium Pharma
Ingredient:naproxen
Patents:0
Pharmacology for NDA: 218497
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 218497
Suppliers and Packaging for NDA: 218497
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN naproxen TABLET, DELAYED RELEASE;ORAL 218497 ANDA ANI Pharmaceuticals, Inc. 70954-925 70954-925-10 100 TABLET, DELAYED RELEASE in 1 BOTTLE (70954-925-10)
NAPROXEN naproxen TABLET, DELAYED RELEASE;ORAL 218497 ANDA ANI Pharmaceuticals, Inc. 70954-928 70954-928-10 100 TABLET, DELAYED RELEASE in 1 BOTTLE (70954-928-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength375MG
Approval Date:Jun 12, 2024TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength500MG
Approval Date:Jun 12, 2024TE:ABRLD:No

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