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Norethindrone acetate - Generic Drug Details

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Norethindrone acetate is the generic ingredient in three branded drugs marketed by Duramed Res, Aurobindo Pharma Ltd, Barr, Amneal Pharms, Jai Pharma 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

Tradenames:3
Patents:0
Applicants:7
NDAs:7
Drug Master File Entries: see list26
Suppliers / Packaging: see list9
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: norethindrone acetate

Ingredient-typeProgesterone Congeners
Drug ClassProgestin

Tentative approvals for NORETHINDRONE ACETATE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET;ORAL1MG;0.01MG;75MG
<disabled><disabled>TABLET;ORAL1MG;0.02MG
<disabled><disabled>TABLET;ORAL75MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Duramed Res
AYGESTIN
norethindrone acetate
TABLET;ORAL018405-001Apr 21, 1982RXYes► subscribe► subscribe
Glenmark Generics
NORETHINDRONE ACETATE
norethindrone acetate
TABLET;ORAL091090-001Jul 21, 2010RXNo► subscribe► subscribe
Jai Pharma Ltd
NORETHINDRONE ACETATE
norethindrone acetate
TABLET;ORAL205278-001Nov 10, 2016RXNo► subscribe► subscribe
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