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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 211253


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NDA 211253 describes DICLOFENAC SODIUM, which is a drug marketed by Actavis Mid Atlantic, Alembic, Amneal, Amneal Pharms, Aurolife Pharma Llc, Cipla, Encube, Glenmark Pharms Ltd, Hikma, Padagis Israel, Perrigo Pharma Intl, Taro, Altaire Pharms Inc, Bausch And Lomb, Falcon Pharms, Rising, Rubicon, Sandoz, Sciegen Pharms Inc, Apotex, Epic Pharma Llc, Lupin Ltd, Lupin Pharms, Novel Labs Inc, Pai Holdings Pharm, Twi Pharms, Watson Labs Inc, Zydus Lifesciences, Actavis Elizabeth, Aurobindo Pharma Usa, Carlsbad, Chartwell Rx, Micro Labs, Pliva, Roxane, Teva, Teva Pharms, Unique, Dexcel Ltd, Riconpharma Llc, Vpna, Actavis Labs Fl Inc, Exela Holdings, Yung Shin Pharm, and Zydus Pharms, and is included in sixty-three NDAs. It is available from one hundred and twenty-six suppliers. Additional details are available on the DICLOFENAC SODIUM profile page.

The generic ingredient in DICLOFENAC SODIUM is diclofenac sodium; misoprostol. There are forty-seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.
Summary for 211253
Tradename:DICLOFENAC SODIUM
Applicant:Perrigo Pharma Intl
Ingredient:diclofenac sodium
Patents:0
Pharmacology for NDA: 211253
Mechanism of ActionCyclooxygenase Inhibitors
Physiological EffectDecreased Prostaglandin Production
Suppliers and Packaging for NDA: 211253
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 211253 ANDA L. Perrigo Company 0113-1189 0113-1189-01 1 TUBE in 1 CARTON (0113-1189-01) / 100 g in 1 TUBE
DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 211253 ANDA L. Perrigo Company 0113-1189 0113-1189-03 150 g in 1 TUBE (0113-1189-03)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:GEL;TOPICALStrength1%
Approval Date:May 16, 2019TE:RLD:No

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