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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 213875


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NDA 213875 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-seven 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 213875
Tradename:DICLOFENAC POTASSIUM
Applicant:Aurobindo Pharma Ltd
Ingredient:diclofenac potassium
Patents:0
Pharmacology for NDA: 213875
Mechanism of ActionCyclooxygenase Inhibitors
Physiological EffectDecreased Prostaglandin Production
Suppliers and Packaging for NDA: 213875
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC POTASSIUM diclofenac potassium CAPSULE;ORAL 213875 ANDA Aurobindo Pharma Limited 59651-353 59651-353-01 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (59651-353-01)
DICLOFENAC POTASSIUM diclofenac potassium CAPSULE;ORAL 213875 ANDA Aurobindo Pharma Limited 59651-353 59651-353-08 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (59651-353-08)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Oct 19, 2021TE:ABRLD:No

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