FDA Orange Book · active-ingredient family
Norethindrone acetate
Norethindrone acetate is approved as 2 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:AYGESTIN · NDA 018405
2
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AYGESTINRLD | DURAMED RES | NDA 018405 | — | Apr 21, 1982 | |
| NORLUTATE | PARKE DAVIS | NDA 012184 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NORETHINDRONE ACETATE | INGENUS PHARMS LLC | ANDA 206490 | AB | Nov 05, 2018 | |
| NORETHINDRONE ACETATE | XIROMED | ANDA 205278 | AB | Nov 10, 2016 | |
| NORETHINDRONE ACETATE | AUROBINDO PHARMA LTD | ANDA 204236 | — | Jan 08, 2016 | |
| NORETHINDRONE ACETATE | AMNEAL PHARMS | ANDA 200275 | AB | Jul 30, 2012 | |
| NORETHINDRONE ACETATE | GLENMARK PHARMS LTD | ANDA 091090 | AB | Jul 21, 2010 | |
| NORETHINDRONE ACETATE | BARR | ANDA 075951 | AB | May 25, 2001 |
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.
Norethindrone acetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
