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Last Updated: August 15, 2020

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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. Eighteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.
Summary for 021241
Applicant:Janssen Pharms
Ingredient:ethinyl estradiol; norgestimate
Paragraph IV (Patent) Challenges for 021241
Tradename Dosage Ingredient NDA Submissiondate
ORTHO TRI-CYCLEN LO TABLET;ORAL-28 ethinyl estradiol; norgestimate 021241

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG
Approval Date:Aug 22, 2002TE:ABRLD:Yes

Expired US Patents for NDA 021241

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Serving leading biopharmaceutical companies globally:

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