Details for New Drug Application (NDA): 021241

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NDA 021241 describes ORTHO TRI-CYCLEN LO, which is a drug marketed by Janssen Pharms and is included in one NDA. Additional details are available on the ORTHO TRI-CYCLEN LO profile page.

The generic ingredient in ORTHO TRI-CYCLEN LO is ethinyl estradiol; norgestimate. There are twenty-six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.

Summary for 021241

Tradename:	ORTHO TRI-CYCLEN LO
Applicant:	Janssen Pharms
Ingredient:	ethinyl estradiol; norgestimate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-28			Strength	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 22, 2002	TE:		RLD:	Yes

Expired US Patents for NDA 021241

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ORTHO TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002	6,214,815*PED	⤷ Subscribe
Janssen Pharms	ORTHO TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002	4,530,839*PED	⤷ Subscribe
Janssen Pharms	ORTHO TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002	4,628,051*PED	⤷ Subscribe
Janssen Pharms	ORTHO TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002	4,616,006*PED	⤷ Subscribe
Janssen Pharms	ORTHO TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002	4,544,554*PED	⤷ Subscribe
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