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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 216548

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NDA 216548 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 216548

Tradename:	DICLOFENAC SODIUM
Applicant:	Rubicon Research
Ingredient:	diclofenac sodium
Patents:	0

Pharmacology for NDA: 216548

Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Prostaglandin Production

Suppliers and Packaging for NDA: 216548

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DICLOFENAC SODIUM	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	216548	ANDA	A-S Medication Solutions	50090-7646	50090-7646-0	100 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7646-0)
DICLOFENAC SODIUM	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	216548	ANDA	A-S Medication Solutions	50090-7646	50090-7646-1	20 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7646-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	25MG
Approval Date:	May 11, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	50MG
Approval Date:	May 11, 2023	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	75MG
Approval Date:	May 11, 2023	TE:	AB	RLD:	No

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