Details for New Drug Application (NDA): 204648

NDA 204648 describes DICLOFENAC POTASSIUM, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, Onesource Specialty, Alkem Labs Ltd, Annora Pharma, Ph Health, Taro, Torrent, Umedica, Chartwell Rx, Novast Labs, Rk Pharma, Rubicon Research, Senores Pharms, Sun Pharm Industries, Teva, and Watson Labs Teva, and is included in eighteen NDAs. It is available from forty-five 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-nine suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.

Summary for 204648

Tradename:	DICLOFENAC POTASSIUM
Applicant:	Bionpharma
Ingredient:	diclofenac potassium
Patents:	0

Pharmacology for NDA: 204648

Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Prostaglandin Production

Suppliers and Packaging for NDA: 204648

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DICLOFENAC POTASSIUM	diclofenac potassium	CAPSULE;ORAL	204648	ANDA	TEVA PHARMACEUTICALS, INC.	0480-9435	0480-9435-89	120 CAPSULE, LIQUID FILLED in 1 BOTTLE (0480-9435-89)
DICLOFENAC POTASSIUM	diclofenac potassium	CAPSULE;ORAL	204648	ANDA	Bryant Ranch Prepack	63629-4871	63629-4871-1	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-4871-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Feb 23, 2016	TE:	AB	RLD:	No

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