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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Healthtrust
US Department of Justice
Boehringer Ingelheim
Deloitte
AstraZeneca
Citi
Novartis
US Army
Daiichi Sankyo

Generated: November 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076785

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NDA 076785 describes KELNOR, which is a drug marketed by Barr and is included in one NDA. It is available from three suppliers. Additional details are available on the KELNOR profile page.

The generic ingredient in KELNOR is ethinyl estradiol; ethynodiol diacetate. 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; ethynodiol diacetate profile page.

Summary for 076785

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 076785

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KELNOR
ethinyl estradiol; ethynodiol diacetate
TABLET;ORAL-28 076785 ANDA Teva Pharmaceuticals USA, Inc. 0555-9064 0555-9064-58 6 POUCH in 1 CARTON (0555-9064-58) > 1 BLISTER PACK in 1 POUCH (0555-9064-79) > 1 KIT in 1 BLISTER PACK
KELNOR
ethinyl estradiol; ethynodiol diacetate
TABLET;ORAL-28 076785 ANDA Mayne Pharma Inc. 51862-260 51862-260-06 6 POUCH in 1 CARTON (51862-260-06) > 1 BLISTER PACK in 1 POUCH (51862-260-01) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG;1MG
Approval Date:May 23, 2005TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

AstraZeneca
Argus Health
US Department of Justice
Cerilliant
QuintilesIMS
Fuji
Healthtrust
Dow
Accenture
Chinese Patent Office

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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