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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 075229


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NDA 075229 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 075229
Tradename:DICLOFENAC POTASSIUM
Applicant:Rubicon
Ingredient:diclofenac potassium
Patents:0
Pharmacology for NDA: 075229
Mechanism of ActionCyclooxygenase Inhibitors
Physiological EffectDecreased Prostaglandin Production
Suppliers and Packaging for NDA: 075229
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 075229 ANDA A-S Medication Solutions 50090-5893 50090-5893-0 30 TABLET, COATED in 1 BOTTLE (50090-5893-0)
DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 075229 ANDA A-S Medication Solutions 50090-5893 50090-5893-1 21 TABLET, COATED in 1 BOTTLE (50090-5893-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Nov 20, 1998TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Sep 16, 2021TE:ABRLD:No

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