FDA Orange Book · active-ingredient family
Estradiol; norethindrone acetate
Estradiol; norethindrone acetate is approved as 2 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ACTIVELLA · NDA 020907
2
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · film, extended release, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ACTIVELLARLD×2 | AMNEAL | NDA 020907 | — | Dec 28, 2006 | |
| COMBIPATCHRLD×2 | NOVEN PHARMS INC | NDA 020870 | — | Aug 07, 1998 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ETYQA×2 | AUROBINDO PHARMA LTD | ANDA 214729 | — | Jun 30, 2023 | |
| ESTRADIOL AND NORETHINDRONE ACETATE×2 | NOVAST LABS | ANDA 210612 | AB | Apr 03, 2019 | |
| ESTRADIOL AND NORETHINDRONE ACETATE | NAARI PTE | ANDA 210233 | AB | Feb 28, 2018 | |
| ESTRADIOL AND NORETHINDRONE ACETATE×2 | XIROMED | ANDA 207261 | AB | Feb 10, 2017 | |
| AMABELZ×2 | LUPIN | ANDA 203339 | BX | Jun 20, 2016 | |
| ESTRADIOL AND NORETHINDRONE ACETATE | TEVA PHARMS USA | ANDA 200747 | — | Mar 08, 2012 | |
| ESTRADIOL AND NORETHINDRONE ACETATE×2 | BRECKENRIDGE PHARM | ANDA 078324 | AB | Jun 09, 2011 | |
| ESTRADIOL AND NORETHINDRONE ACETATE | BARR | ANDA 079193 | AB | May 11, 2010 |
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.
Estradiol; norethindrone acetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
