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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 203383


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NDA 203383 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 203383
Tradename:DICLOFENAC SODIUM
Applicant:Altaire Pharms Inc
Ingredient:diclofenac sodium
Patents:0
Pharmacology for NDA: 203383
Mechanism of ActionCyclooxygenase Inhibitors
Physiological EffectDecreased Prostaglandin Production
Suppliers and Packaging for NDA: 203383
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC SODIUM diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 203383 ANDA Altaire Pharmaceuticals Inc. 59390-149 59390-149-02 1 BOTTLE, DROPPER in 1 CARTON (59390-149-02) / 2.5 mL in 1 BOTTLE, DROPPER
DICLOFENAC SODIUM diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 203383 ANDA Altaire Pharmaceuticals Inc. 59390-149 59390-149-05 1 BOTTLE, DROPPER in 1 CARTON (59390-149-05) / 5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.1%
Approval Date:Nov 16, 2015TE:ATRLD:No

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