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Last Updated: December 13, 2025

Details for New Drug Application (NDA): 019190

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NDA 019190 describes TRIPHASIL-28, which is a drug marketed by Wyeth Pharms Inc and is included in one NDA. Additional details are available on the TRIPHASIL-28 profile page.

The generic ingredient in TRIPHASIL-28 is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for 019190

Tradename:	TRIPHASIL-28
Applicant:	Wyeth Pharms Inc
Ingredient:	ethinyl estradiol; levonorgestrel
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-28			Strength	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 1, 1984	TE:		RLD:	Yes

Expired US Patents for NDA 019190

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms Inc	TRIPHASIL-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	019190-001	Nov 1, 1984	3,666,858	⤷ Get Started Free
Wyeth Pharms Inc	TRIPHASIL-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	019190-001	Nov 1, 1984	3,959,322	⤷ Get Started Free
Wyeth Pharms Inc	TRIPHASIL-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	019190-001	Nov 1, 1984	3,957,982	⤷ Get Started Free
Wyeth Pharms Inc	TRIPHASIL-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	019190-001	Nov 1, 1984	3,850,911	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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