Details for New Drug Application (NDA): 021040

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NDA 021040 describes PREFEST, which is a drug marketed by Teva Womens and is included in one NDA. Additional details are available on the PREFEST profile page.

The generic ingredient in PREFEST is estradiol; norgestimate. There are seventy-five drug master file entries for this compound. Additional details are available on the estradiol; norgestimate profile page.

Summary for 021040

Tradename:	PREFEST
Applicant:	Teva Womens
Ingredient:	estradiol; norgestimate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1MG,1MG;N/A,0.09MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 22, 1999	TE:		RLD:	Yes

Expired US Patents for NDA 021040

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Womens	PREFEST	estradiol; norgestimate	TABLET;ORAL	021040-001	Oct 22, 1999	⤷ Sign Up	⤷ Sign Up
Teva Womens	PREFEST	estradiol; norgestimate	TABLET;ORAL	021040-001	Oct 22, 1999	⤷ Sign Up	⤷ Sign Up
Teva Womens	PREFEST	estradiol; norgestimate	TABLET;ORAL	021040-001	Oct 22, 1999	⤷ Sign Up	⤷ Sign Up
Teva Womens	PREFEST	estradiol; norgestimate	TABLET;ORAL	021040-001	Oct 22, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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