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Generated: December 12, 2018

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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, Amneal Pharms, Cipla, Glenmark Pharms Ltd, Perrigo Uk Finco, Taro, Tolmar, Akorn, Altaire Pharms Inc, Anda Repository, Apotex Inc, Bausch And Lomb, Falcon Pharms, Sandoz Inc, Lupin Ltd, Novel Labs Inc, Riconpharma Llc, Teligent Pharma Inc, Twi Pharms, Watson Labs Inc, Zydus Pharms Usa Inc, Actavis Elizabeth, Allied, Carlsbad, Casi Pharms Inc, Mylan Pharms Inc, Pliva, Roxane, Teva, Teva Pharms, Unique Pharm Labs, Dexcel Ltd, Mylan, Vpna, Actavis Labs Fl Inc, Exela Holdings, and Sandoz, and is included in forty-five NDAs. It is available from eighty-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. Fifteen 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 203383
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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