FDA Orange Book · active-ingredient family
Testosterone propionate
Testosterone propionate is approved in 8 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TESTOSTERONE PROPIONATE | BEL MAR | ANDA 080741 | — | Approved Prior to Jan 1, 1982 | |
| TESTOSTERONE PROPIONATE | BEL MAR | ANDA 080742 | — | Approved Prior to Jan 1, 1982 | |
| TESTOSTERONE PROPIONATE | BEL MAR | ANDA 080743 | — | Approved Prior to Jan 1, 1982 | |
| TESTOSTERONE PROPIONATE | ELKINS SINN | ANDA 080276 | — | Approved Prior to Jan 1, 1982 | |
| TESTOSTERONE PROPIONATE | LILLY | ANDA 080254 | — | Approved Prior to Jan 1, 1982 | |
| TESTOSTERONE PROPIONATE×3 | WATSON LABS | ANDA 080188 | — | Approved Prior to Jan 1, 1982 | |
| TESTOSTERONE PROPIONATE×2 | WATSON LABS | ANDA 085490 | — | Approved Prior to Jan 1, 1982 | |
| TESTOSTERONE PROPIONATE | WATSON LABS | ANDA 083595 | — | Approved Prior to Jan 1, 1982 |
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.
Testosterone propionate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
