FDA Orange Book · active-ingredient family
Tobramycin sulfate
Tobramycin sulfate is approved as 3 brand and 33 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NEBCIN · NDA 050519
3
Brand (NDA)
33
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NEBCINRLD | LILLY | NDA 050519 | — | Approved Prior to Jan 1, 1982 | |
| NEBCINRLD | LILLY | NDA 050477 | — | Approved Prior to Jan 1, 1982 | |
| TOBRAMYCIN SULFATE | FRESENIUS KABI USA | NDA 050789 | AP | Jul 13, 2004 |
Generic (ANDA) products (33)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TOBRAMYCIN SULFATE | EUGIA PHARMA | ANDA 217519 | AP | Jun 21, 2023 | |
| TOBRAMYCIN SULFATE | SLATE RUN PHARMA | ANDA 217029 | AP | Feb 01, 2023 | |
| TOBRAMYCIN SULFATE | GLAND | ANDA 211189 | AP | May 18, 2021 | |
| TOBRAMYCIN SULFATE×2 | GLAND | ANDA 209621 | AP | Feb 11, 2021 | |
| TOBRAMYCIN SULFATE (PHARMACY BULK) | GLAND | ANDA 209346 | AP | Feb 09, 2021 | |
| TOBRAMYCIN SULFATE | BAXTER HLTHCARE CORP | ANDA 206965 | AP | Jul 01, 2016 | |
| TOBRAMYCIN SULFATE | EPIC PHARMA LLC | ANDA 205179 | — | Sep 16, 2014 | |
| TOBRAMYCIN SULFATE | XELLIA PHARMS APS | ANDA 205685 | AP | Sep 16, 2014 | |
| TOBRAMYCIN SULFATE | MYLAN LABS LTD | ANDA 065407 | AP | Mar 11, 2008 | |
| TOBRAMYCIN SULFATE×2 | FRESENIUS KABI USA | ANDA 065122 | AP | Nov 29, 2002 | |
| TOBRAMYCIN SULFATE (PHARMACY BULK) | FRESENIUS KABI USA | ANDA 065120 | AP | Nov 29, 2002 | |
| TOBRAMYCIN SULFATE | XGEN PHARMS | ANDA 065013 | AP | Aug 17, 2001 | |
| TOBRAMYCIN SULFATE | IGI LABS INC | ANDA 063119 | — | Oct 31, 1994 | |
| TOBRAMYCIN SULFATE | IGI LABS INC | ANDA 063120 | — | Oct 31, 1994 | |
| TOBRAMYCIN SULFATE | IGI LABS INC | ANDA 063121 | — | Oct 31, 1994 | |
| TOBRAMYCIN SULFATE | IGI LABS INC | ANDA 063122 | — | Oct 31, 1994 | |
| TOBRAMYCIN SULFATE×2 | APOTHECON | ANDA 064021 | — | May 31, 1994 | |
| TOBRAMYCIN SULFATE | APOTHECON | ANDA 064026 | — | May 31, 1994 | |
| TOBRAMYCIN SULFATE (PHARMACY BULK) | HOSPIRA | ANDA 063116 | — | May 18, 1992 | |
| TOBRAMYCIN SULFATE | TEVA PHARMS USA | ANDA 063100 | — | Jan 30, 1992 | |
| TOBRAMYCIN SULFATE | HIKMA | ANDA 063128 | — | Nov 27, 1991 | |
| TOBRAMYCIN SULFATE | HIKMA | ANDA 063127 | — | Nov 27, 1991 | |
| TOBRAMYCIN SULFATE | HIKMA | ANDA 063118 | — | Jul 29, 1991 | |
| TOBRAMYCIN SULFATE | HOSPIRA | ANDA 063161 | — | May 29, 1991 | |
| TOBRAMYCIN SULFATE | HOSPIRA | ANDA 063080 | — | Apr 30, 1991 | |
| TOBRAMYCIN SULFATE | HOSPIRA | ANDA 063112 | — | Apr 30, 1991 | |
| TOBRAMYCIN SULFATE | HOSPIRA | ANDA 063111 | AP | Apr 30, 1991 | |
| TOBRAMYCIN SULFATE | HIKMA | ANDA 063113 | — | Apr 26, 1991 | |
| TOBRAMYCIN SULFATE | HIKMA | ANDA 063117 | AP | Apr 26, 1991 | |
| TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×3 | HOSPIRA | ANDA 063081 | — | Jul 31, 1990 | |
| TOBRAMYCIN SULFATE×2 | WATSON LABS INC | ANDA 062945 | — | Aug 09, 1989 | |
| NEBCIN | LILLY | ANDA 062707 | — | Apr 29, 1987 | |
| NEBCIN×2 | LILLY | ANDA 062008 | — | 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.
Tobramycin sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
