FDA Orange Book · active-ingredient family
Estradiol cypionate; testosterone cypionate
Estradiol cypionate; testosterone cypionate is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DEPO-TESTADIOL · NDA 017968
1
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DEPO-TESTADIOL | PHARMACIA AND UPJOHN | NDA 017968 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TESTOSTERONE CYPIONATE-ESTRADIOL CYPIONATE | WATSON LABS | ANDA 085603 | — | Mar 13, 1986 |
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 cypionate; testosterone cypionate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
