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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Daiichi Sankyo
US Army

Generated: September 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020301

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NDA 020301 describes ORTHO-CEPT, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the ORTHO-CEPT profile page.

The generic ingredient in ORTHO-CEPT is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.

Summary for NDA: 020301

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020301

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
desogestrel; ethinyl estradiol
TABLET;ORAL-21 020301 NDA Janssen Pharmaceuticals, Inc. 50458-196 50458-196-15 6 DIALPACK in 1 CARTON (50458-196-15) > 1 KIT in 1 DIALPACK (50458-196-01)
desogestrel; ethinyl estradiol
TABLET;ORAL-28 020301 NDA Janssen Pharmaceuticals, Inc. 50458-196 50458-196-15 6 DIALPACK in 1 CARTON (50458-196-15) > 1 KIT in 1 DIALPACK (50458-196-01)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-21Strength0.15MG;0.03MG
Approval Date:Dec 14, 1992TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-28Strength0.15MG;0.03MG
Approval Date:Dec 14, 1992TE:RLD:No

Expired Orange Book Patents for NDA: 020301

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
desogestrel; ethinyl estradiol
TABLET;ORAL-21020301-001Dec 14, 1992► Subscribe► Subscribe
Janssen Pharms
desogestrel; ethinyl estradiol
TABLET;ORAL-28020301-002Dec 14, 1992► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
US Department of Justice
Federal Trade Commission
Queensland Health
Daiichi Sankyo

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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