FDA Orange Book · active-ingredient family
Dexamethasone; tobramycin
Dexamethasone; tobramycin is approved as 3 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TOBRADEX ST · NDA 050818
3
Brand (NDA)
3
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · ointment, suspension/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TOBRADEX STRLD | HARROW EYE | NDA 050818 | — | Feb 13, 2009 | |
| TOBRADEXRLD | NOVARTIS | NDA 050616 | — | Sep 28, 1988 | |
| TOBRADEXRLD | SANDOZ | NDA 050592 | AB | Aug 18, 1988 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TOBRAMYCIN AND DEXAMETHASONE | PADAGIS US | ANDA 212715 | AB | Feb 11, 2022 | |
| TOBRAMYCIN AND DEXAMETHASONE | AMNEAL | ANDA 212991 | — | Jul 15, 2021 | |
| TOBRAMYCIN AND DEXAMETHASONE | BAUSCH AND LOMB INC | ANDA 064134 | AB | Oct 27, 1999 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8101582 | Dec 19, 2027 | in 1 yr 6 mo | ProductU-1082 |
| 8450287 | Dec 19, 2027 | in 1 yr 6 mo | Product |
| 7795316 | Aug 03, 2028 | in 2 yr 2 mo | ProductU-1082 |
Dexamethasone; tobramycin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
