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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 075281

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NDA 075281 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, Sun Pharma Canada, Altaire Pharms Inc, Bausch And Lomb, Falcon Pharms, Rising, Rubicon Research, 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, Umedica, Unique, Dexcel Ltd, Novast Labs, Vpna, Actavis Labs Fl Inc, Exela Holdings, Yung Shin Pharm, and Zydus Pharms, and is included in sixty-five 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 075281

Tradename:	DICLOFENAC SODIUM
Applicant:	Aurobindo Pharma Usa
Ingredient:	diclofenac sodium
Patents:	0

Pharmacology for NDA: 075281

Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Prostaglandin Production

Suppliers and Packaging for NDA: 075281

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DICLOFENAC SODIUM	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	075281	ANDA	Aurobindo Pharma Limited	59651-842	59651-842-01	100 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-842-01)
DICLOFENAC SODIUM	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	075281	ANDA	Aurobindo Pharma Limited	59651-842	59651-842-60	60 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-842-60)

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	50MG
Approval Date:	Feb 12, 2002	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	75MG
Approval Date:	Feb 12, 2002	TE:	AB	RLD:	No

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