Orange Book product · Brand (NDA)
AYGESTIN
NORETHINDRONE ACETATE
At a glance
Apr 21, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 21, 1982
44 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
NORETHINDRONE ACETATE
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 018405
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.
- —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
- 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.
