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Last Updated: January 27, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208077

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NDA 208077 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 208077
Applicant:Amneal Pharms
Ingredient:diclofenac sodium
Formulation / Manufacturing:see details
Pharmacology for NDA: 208077
Suppliers and Packaging for NDA: 208077
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 208077 ANDA ATLANTIC BIOLOGICALS CORP. 17856-0833 17856-0833-1 120 SYRINGE in 1 BOTTLE, UNIT-DOSE (17856-0833-1) > 1 g in 1 SYRINGE
DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 208077 ANDA AvKARE, Inc. 42291-256 42291-256-11 1 TUBE in 1 CARTON (42291-256-11) > 100 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength1%
Approval Date:Mar 18, 2016TE:ABRLD:No

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