Orange Book product · Generic (ANDA)
INCASSIA
NORETHINDRONE
At a glance
Sep 23, 2016
Approved
Generic (ANDA)
Application
AB1
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 23, 2016
9 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
NORETHINDRONE
Strength
0.35MG
Dosage form
TABLET
Route
ORAL-28
TE code
AB1
Application
ANDA 207304
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of NORETHINDRONE
- —NORLUTINBrand (NDA)
NDA 010895 · PARKE DAVIS
- —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
- 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.
