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FDA Orange Book · active-ingredient family

Norethindrone

Norethindrone is approved as 3 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:MICRONOR · NDA 016954

3

Brand (NDA)

14

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
MICRONORRLDJANSSEN PHARMSNDA 016954—Approved Prior to Jan 1, 1982
NOR-QDRLDTEVA BRANDED PHARMNDA 017060AB1Approved Prior to Jan 1, 1982
NORLUTINPARKE DAVISNDA 010895—Approved Prior to Jan 1, 1982

Generic (ANDA) products (14)

ProductApplicantApplicationTEApproved
EMZAHHAUROBINDO PHARMAANDA 216796AB2Jan 06, 2023
NORETHINDRONENAARI PTEANDA 206807AB1Dec 13, 2016
INCASSIAAUROBINDO PHARMAANDA 207304AB1Sep 23, 2016
NORETHINDRONENOVAST LABSANDA 200961AB2Sep 13, 2013
NORETHINDRONENOVAST LABSANDA 202014AB1Sep 13, 2013
NORETHINDRONEAMNEAL PHARMSANDA 202260—Aug 01, 2013
NORETHINDRONEXIROMEDANDA 201483AB1Jun 24, 2013
NORETHINDRONEXIROMEDANDA 200980AB2Jun 12, 2013
JENCYCLALUPIN LTDANDA 091323AB2Mar 28, 2013
NORETHINDRONELUPIN LTDANDA 091325AB1Sep 19, 2011
NORETHINDRONEGLENMARK PHARMS LTDANDA 091209AB2Jul 22, 2010
HEATHERGLENMARK PHARMS LTDANDA 090454AB1Apr 23, 2010
CAMILADR REDDYS LABS SAANDA 076177AB1Oct 21, 2002
ERRINDR REDDYS LABS SAANDA 076225AB2Oct 21, 2002

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Norethindrone — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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