FDA Orange Book · active-ingredient family
Tamoxifen citrate
Tamoxifen citrate is approved as 2 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SOLTAMOX · NDA 021807
2
Brand (NDA)
12
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SOLTAMOXRLD | MAYNE PHARMA COMMRCL | NDA 021807 | — | Oct 29, 2005 | |
| NOLVADEXRLD×2 | ASTRAZENECA | NDA 017970 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TAMOXIFEN CITRATE×2 | EUGIA PHARMA | ANDA 213358 | AB | Aug 14, 2020 | |
| TAMOXIFEN CITRATE×2 | ZYDUS PHARMS | ANDA 206694 | AB | Oct 27, 2017 | |
| TAMOXIFEN CITRATE×2 | APOTEX | ANDA 090878 | — | Sep 23, 2011 | |
| TAMOXIFEN CITRATE×2 | TEVA | ANDA 074504 | — | Apr 28, 2003 | |
| TAMOXIFEN CITRATE×2 | AEGIS PHARMS | ANDA 076398 | — | Mar 31, 2003 | |
| TAMOXIFEN CITRATE | PHARMACHEMIE | ANDA 074539 | — | Mar 31, 2003 | |
| TAMOXIFEN CITRATE×2 | ACTAVIS LABS FL INC | ANDA 070929 | AB | Feb 20, 2003 | |
| TAMOXIFEN CITRATE×2 | ACTAVIS LABS FL INC | ANDA 076179 | — | Feb 20, 2003 | |
| TAMOXIFEN CITRATE×2 | DR REDDYS LABS SA | ANDA 075797 | AB | Feb 20, 2003 | |
| TAMOXIFEN CITRATE×2 | IVAX SUB TEVA PHARMS | ANDA 075740 | — | Feb 20, 2003 | |
| TAMOXIFEN CITRATE×2 | MYLAN | ANDA 074732 | AB | Feb 20, 2003 | |
| TAMOXIFEN CITRATE×2 | ROXANE | ANDA 076027 | — | Feb 20, 2003 |
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.
Tamoxifen citrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
