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Last Updated: January 27, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206493

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NDA 206493 describes DICLOFENAC SODIUM, which is a drug marketed by Actavis Mid Atlantic, Amneal Pharms, Cipla, Glenmark Pharms Ltd, Hi Tech, Mylan, Perrigo Uk Finco, Taro, Tolmar, Akorn, Altaire Pharms Inc, Apotex Inc, Bausch And Lomb, Falcon Pharms, Rising, Sandoz Inc, Mylan Labs Ltd, Lupin Ltd, Novel Labs Inc, Riconpharma Llc, Teligent Pharma Inc, Twi Pharms, Watson Labs Inc, Zydus Pharms, Actavis Elizabeth, Allied, Carlsbad, Casi Pharms Inc, Mylan Pharms Inc, Pliva, Roxane, Teva, Teva Pharms, Unique Pharm Labs, Dexcel Ltd, Vpna, Actavis Labs Fl Inc, Exela Holdings, and Sandoz, and is included in forty-nine NDAs. It is available from sixty-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. Eleven suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.
Summary for 206493
Tradename:DICLOFENAC SODIUM
Applicant:Actavis Mid Atlantic
Ingredient:diclofenac sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206493
Suppliers and Packaging for NDA: 206493
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 206493 ANDA Actavis Pharma, Inc. 0472-1783 0472-1783-10 1 TUBE in 1 CARTON (0472-1783-10) > 100 g in 1 TUBE
DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 206493 ANDA Preferred Pharmaceuticals, Inc. 68788-7518 68788-7518-1 1 TUBE in 1 CARTON (68788-7518-1) > 100 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength3%
Approval Date:Dec 2, 2015TE:ABRLD:No

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