Orange Book product · Brand (NDA)
MICRONOR
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
0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL-28
TE code
Not listed
Application
NDA 016954
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- —NORLUTINBrand (NDA)
NDA 010895 · PARKE DAVIS
- —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.
