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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 074190


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Summary for 074190
Tradename:NAPROXEN
Applicant:Hikma
Ingredient:naproxen
Patents:0
Pharmacology for NDA: 074190
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 074190
Suppliers and Packaging for NDA: 074190
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN naproxen SUSPENSION;ORAL 074190 ANDA Hikma Pharmaceuticals USA Inc. 0054-3630 0054-3630-63 500 mL in 1 BOTTLE, PLASTIC (0054-3630-63)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength25MG/ML
Approval Date:Mar 30, 1994TE:ABRLD:No

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