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Covington
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Federal Trade Commission
Queensland Health
US Army
QuintilesIMS
Fuji
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Generated: April 19, 2018

DrugPatentWatch Database Preview

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. It is available from two suppliers. There is one patent protecting this drug. 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-three 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
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 019697
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-21 019697 NDA Rebel Distributors Corp 21695-407 E 21695-407-01
ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-21 019697 NDA Physicians Total Care, Inc. 54868-5826 E 54868-5826-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG
Approval Date:Jul 3, 1992TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-21Strength0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG
Approval Date:Jul 3, 1992TE:RLD:No

Expired US Patents for NDA 019697

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 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-21 019697-002 Jul 3, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-21 019697-002 Jul 3, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-21 019697-002 Jul 3, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Daiichi Sankyo
QuintilesIMS
Cantor Fitzgerald
Johnson and Johnson
Accenture
Julphar
Medtronic
McKesson

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