Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Chinese Patent Office
Boehringer Ingelheim
Harvard Business School
Daiichi Sankyo

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075288

« Back to Dashboard

NDA 075288 describes LOW-OGESTREL-28, which is a drug marketed by Mayne Pharma and is included in one NDA. It is available from two suppliers. Additional details are available on the LOW-OGESTREL-28 profile page.

The generic ingredient in LOW-OGESTREL-28 is ethinyl estradiol; norgestrel. There are twenty-six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.
Summary for 075288
Applicant:Mayne Pharma
Ingredient:ethinyl estradiol; norgestrel
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 075288
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOW-OGESTREL-21 ethinyl estradiol; norgestrel TABLET;ORAL-21 075288 ANDA Mayne Pharma Inc. 51862-564 N 51862-564-06
LOW-OGESTREL-21 ethinyl estradiol; norgestrel TABLET;ORAL-21 075288 ANDA Physicians Total Care, Inc. 54868-4850 E 54868-4850-0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-21Strength0.03MG;0.3MG
Approval Date:Jul 28, 1999TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.03MG;0.3MG
Approval Date:Jul 28, 1999TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
US Department of Justice

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.