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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 218011


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NDA 218011 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 218011
Tradename:DICLOFENAC POTASSIUM
Applicant:Taro
Ingredient:diclofenac potassium
Patents:0
Pharmacology for NDA: 218011
Mechanism of ActionCyclooxygenase Inhibitors
Physiological EffectDecreased Prostaglandin Production
Suppliers and Packaging for NDA: 218011
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC POTASSIUM diclofenac potassium FOR SOLUTION;ORAL 218011 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4240 51672-4240-6 9 PACKET in 1 CARTON (51672-4240-6) / 1 POWDER, FOR SOLUTION in 1 PACKET (51672-4240-8)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength50MG
Approval Date:Jun 14, 2024TE:ABRLD:No

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