Orange Book product · Brand (NDA)
NORLUTATE
NORETHINDRONE ACETATE
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 ACETATE
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 012184
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.
- 1982AYGESTINBrand (NDA)
NDA 018405 · DURAMED RES
- 2018NORETHINDRONE ACETATEGeneric (ANDA)
ANDA 206490 · INGENUS PHARMS LLC
- 2016NORETHINDRONE ACETATEGeneric (ANDA)
ANDA 205278 · XIROMED
- 2016NORETHINDRONE ACETATEGeneric (ANDA)
ANDA 204236 · AUROBINDO PHARMA LTD
- 2012NORETHINDRONE ACETATEGeneric (ANDA)
ANDA 200275 · AMNEAL PHARMS
- 2010NORETHINDRONE ACETATEGeneric (ANDA)
ANDA 091090 · GLENMARK PHARMS LTD
- 2001NORETHINDRONE ACETATEGeneric (ANDA)
ANDA 075951 · BARR
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.
