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Last Updated: December 24, 2024

Details for New Drug Application (NDA): 202964


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NDA 202964 describes DICLOFENAC POTASSIUM, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, Strides Pharma, Alkem Labs Ltd, Annora Pharma, Endo Operations, Taro, Chartwell Rx, Novast Labs, Rk Pharma, Rubicon, Senores Pharms, Sun Pharm Industries, Teva, Umedica, and Watson Labs Teva, and is included in sixteen NDAs. It is available from thirty-eight suppliers. Additional details are available on the DICLOFENAC POTASSIUM profile page.

The generic ingredient in DICLOFENAC POTASSIUM is diclofenac potassium. There are forty-seven drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.
Summary for 202964
Tradename:DICLOFENAC POTASSIUM
Applicant:Endo Operations
Ingredient:diclofenac potassium
Patents:0
Pharmacology for NDA: 202964
Mechanism of ActionCyclooxygenase Inhibitors
Physiological EffectDecreased Prostaglandin Production
Suppliers and Packaging for NDA: 202964
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC POTASSIUM diclofenac potassium FOR SOLUTION;ORAL 202964 ANDA Endo USA, Inc. 49884-905 49884-905-64 9 POWDER, FOR SOLUTION in 1 CARTON (49884-905-64)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength50MG
Approval Date:May 2, 2016TE:ABRLD:No

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