Details for New Drug Application (NDA): 020607

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NDA 020607 describes ARTHROTEC, which is a drug marketed by Pfizer and is included in one NDA. It is available from three suppliers. Additional details are available on the ARTHROTEC profile page.

The generic ingredient in ARTHROTEC 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 020607

Tradename:	ARTHROTEC
Applicant:	Pfizer
Ingredient:	diclofenac sodium; misoprostol
Patents:	0

Pharmacology for NDA: 020607

Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Prostaglandin Production

Suppliers and Packaging for NDA: 020607

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607	NDA	Pfizer Laboratories Div Pfizer Inc	0025-1411	0025-1411-60	60 TABLET, FILM COATED in 1 BOTTLE (0025-1411-60)
ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607	NDA	Pfizer Laboratories Div Pfizer Inc	0025-1411	0025-1411-90	90 TABLET, FILM COATED in 1 BOTTLE (0025-1411-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	50MG;0.2MG
Approval Date:	Dec 24, 1997	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	75MG;0.2MG
Approval Date:	Dec 24, 1997	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020607

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-002	Dec 24, 1997	5,601,843	⤷ Subscribe
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-001	Dec 24, 1997	4,301,146	⤷ Subscribe
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-002	Dec 24, 1997	5,698,225	⤷ Subscribe
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-002	Dec 24, 1997	4,301,146	⤷ Subscribe
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