Details for New Drug Application (NDA): 019697

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NDA 019697 describes ORTHO TRI-CYCLEN, which is a drug marketed by Janssen Pharms and is included in two NDAs. Additional details are available on the ORTHO TRI-CYCLEN profile page.

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

Summary for 019697

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-28			Strength	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 3, 1992	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-21			Strength	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 3, 1992	TE:		RLD:	No

Expired US Patents for NDA 019697

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-21	019697-002	Jul 3, 1992	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-21	019697-002	Jul 3, 1992	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-28	019697-001	Jul 3, 1992	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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