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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Harvard Business School
Cantor Fitzgerald
Farmers Insurance
US Department of Justice

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075288

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NDA 075288 describes LOW-OGESTREL-28, which is a drug marketed by Mayne Pharma and is included in one NDA. It is available from three 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. Five suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.

Summary for 075288

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 51862-564-06 6 BLISTER PACK in 1 CARTON (51862-564-06) > 1 KIT in 1 BLISTER PACK (51862-564-01)
LOW-OGESTREL-21 ethinyl estradiol; norgestrel TABLET;ORAL-21 075288 ANDA Actavis Pharma, Inc. 52544-847 52544-847-28 6 BLISTER PACK in 1 CARTON (52544-847-28) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

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

Summary for product number 002

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

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Cantor Fitzgerald
Boehringer Ingelheim

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