Details for New Drug Application (NDA): 213875

NDA 213875 describes DICLOFENAC POTASSIUM, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, Strides Pharma, Alkem Labs Ltd, Annora Pharma, Endo Operations, Taro, Chartwell Rx, Novast Labs, Rk Pharma, Rubicon, Senores Pharms, Sun Pharm Industries, Teva, Umedica, and Watson Labs Teva, and is included in sixteen NDAs. It is available from thirty-eight suppliers. Additional details are available on the DICLOFENAC POTASSIUM profile page.

The generic ingredient in DICLOFENAC POTASSIUM is diclofenac potassium. There are forty-seven drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.

Summary for 213875

Tradename:	DICLOFENAC POTASSIUM
Applicant:	Aurobindo Pharma Ltd
Ingredient:	diclofenac potassium
Patents:	0

Pharmacology for NDA: 213875

Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Prostaglandin Production

Suppliers and Packaging for NDA: 213875

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DICLOFENAC POTASSIUM	diclofenac potassium	CAPSULE;ORAL	213875	ANDA	Aurobindo Pharma Limited	59651-353	59651-353-01	100 CAPSULE, LIQUID FILLED in 1 BOTTLE (59651-353-01)
DICLOFENAC POTASSIUM	diclofenac potassium	CAPSULE;ORAL	213875	ANDA	Aurobindo Pharma Limited	59651-353	59651-353-08	120 CAPSULE, LIQUID FILLED in 1 BOTTLE (59651-353-08)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Oct 19, 2021	TE:	AB	RLD:	No

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