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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 215787


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NDA 215787 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 215787
Tradename:DICLOFENAC POTASSIUM
Applicant:Senores Pharms
Ingredient:diclofenac potassium
Patents:0
Pharmacology for NDA: 215787
Mechanism of ActionCyclooxygenase Inhibitors
Physiological EffectDecreased Prostaglandin Production
Suppliers and Packaging for NDA: 215787
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 215787 ANDA Cintex Services, LLC 24470-924 24470-924-60 60 TABLET in 1 BOTTLE (24470-924-60)
DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 215787 ANDA Amici Pharmaceuticals LLC 69292-552 69292-552-01 100 TABLET in 1 BOTTLE (69292-552-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Mar 15, 2023TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Nov 9, 2023TE:ABRLD:No

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