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Serving 500+ biopharmaceutical companies globally:

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Generated: June 22, 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 NDA: 075288

Tradename:
2
Applicant:
1
Ingredient:
1
Patents:1
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 500+ biopharmaceutical companies globally:

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Deloitte

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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