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Last Updated: December 23, 2024

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, 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-four 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 208077

Tradename:	DICLOFENAC SODIUM
Applicant:	Amneal Pharms
Ingredient:	diclofenac sodium
Patents:	0

Pharmacology for NDA: 208077

Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Prostaglandin Production

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	Walgreens	0363-1210	0363-1210-17	1 TUBE in 1 CARTON (0363-1210-17) / 50 g in 1 TUBE
DICLOFENAC SODIUM	diclofenac sodium	GEL;TOPICAL	208077	ANDA	Walgreens	0363-1210	0363-1210-35	1 TUBE in 1 CARTON (0363-1210-35) / 100 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	GEL;TOPICAL			Strength	1%
Approval Date:	Mar 18, 2016	TE:		RLD:	No

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