Orange Book product · Generic (ANDA)
NORETHINDRONE ACETATE
NORETHINDRONE ACETATE
At a glance
May 25, 2001
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 25, 2001
25 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
NORETHINDRONE ACETATE
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 075951
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of NORETHINDRONE ACETATE
- 1982AYGESTINBrand (NDA)
NDA 018405 · DURAMED RES
- —NORLUTATEBrand (NDA)
NDA 012184 · PARKE DAVIS
- 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
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.
