Last Updated: August 8, 2026

Details for New Drug Application (NDA): 078792

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NDA 078792 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, Apotex, Epic Pharma Llc, Lupin, 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, Ingenus Pharms Llc, 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-two 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 078792

Tradename:	DICLOFENAC SODIUM
Applicant:	Bausch And Lomb
Ingredient:	diclofenac sodium
Patents:	0

Pharmacology for NDA: 078792

Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Prostaglandin Production

Suppliers and Packaging for NDA: 078792

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DICLOFENAC SODIUM	diclofenac sodium	SOLUTION/DROPS;OPHTHALMIC	078792	ANDA	Bausch & Lomb Incorporated	24208-457	24208-457-05	1 BOTTLE, DROPPER in 1 CARTON (24208-457-05) / 5 mL in 1 BOTTLE, DROPPER
DICLOFENAC SODIUM	diclofenac sodium	SOLUTION/DROPS;OPHTHALMIC	078792	ANDA	Bausch & Lomb Incorporated	24208-457	24208-457-25	1 BOTTLE, DROPPER in 1 CARTON (24208-457-25) / 2.5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.1%
Approval Date:	Dec 28, 2007	TE:	AT	RLD:	No

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