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Norethindrone acetate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for norethindrone acetate?

Norethindrone acetate is the generic ingredient in three branded drugs marketed by Duramed Res, Aurobindo Pharma Ltd, Barr, Amneal Pharms, Mylan Labs Ltd, Parke Davis, and Glenmark Generics, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for norethindrone acetate. Nine suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: norethindrone acetate

Drug Master File Entries: see list26
Suppliers / Packagers: see list9
Bulk Api Vendors: see list58
Clinical Trials: see list446
Patent Applications: see list1,939
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:norethindrone acetate at DailyMed

Pharmacology for Ingredient: norethindrone acetate

Ingredient-typeProgesterone Congeners
Drug ClassProgestin

Tentative approvals for NORETHINDRONE ACETATE

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET;ORAL1MG;0.01MG;75MG
► Subscribe► SubscribeTABLET;ORAL1MG;0.02MG
► Subscribe► SubscribeTABLET;ORAL75MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Duramed Res
norethindrone acetate
TABLET;ORAL018405-001Apr 21, 1982RXYesYes► Subscribe► Subscribe
Amneal Pharms
norethindrone acetate
TABLET;ORAL200275-001Jul 30, 2012RXNoNo► Subscribe► Subscribe
Parke Davis
norethindrone acetate
TABLET;ORAL012184-002Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Mylan Labs Ltd
norethindrone acetate
TABLET;ORAL205278-001Nov 10, 2016RXNoNo► Subscribe► Subscribe
Aurobindo Pharma Ltd
norethindrone acetate
TABLET;ORAL204236-001Jan 8, 2016RXNoNo► Subscribe► Subscribe
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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.