Orange Book product · Brand (NDA)
NORLUTIN
NORETHINDRONE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
NORETHINDRONE
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 010895
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- —MICRONORBrand (NDA)
NDA 016954 · JANSSEN PHARMS
- —NOR-QDBrand (NDA)
NDA 017060 · TEVA BRANDED PHARM
- 2023EMZAHHGeneric (ANDA)
ANDA 216796 · AUROBINDO PHARMA
- 2016NORETHINDRONEGeneric (ANDA)
ANDA 206807 · NAARI PTE
- 2016INCASSIAGeneric (ANDA)
ANDA 207304 · AUROBINDO PHARMA
- 2013NORETHINDRONEGeneric (ANDA)
ANDA 200961 · NOVAST LABS
- 2013NORETHINDRONEGeneric (ANDA)
ANDA 202014 · NOVAST LABS
- 2013NORETHINDRONEGeneric (ANDA)
ANDA 202260 · AMNEAL PHARMS
- 2013NORETHINDRONEGeneric (ANDA)
ANDA 201483 · XIROMED
- 2013NORETHINDRONEGeneric (ANDA)
ANDA 200980 · XIROMED
- 2013JENCYCLAGeneric (ANDA)
ANDA 091323 · LUPIN LTD
- 2011NORETHINDRONEGeneric (ANDA)
ANDA 091325 · LUPIN LTD
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.
