Orange Book product · Brand (NDA)
TOBRAMYCIN SULFATE
TOBRAMYCIN SULFATE
At a glance
Jul 13, 2004
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 13, 2004
22 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
TOBRAMYCIN SULFATE
Strength
EQ 1.2GM BASE/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 050789
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- —NEBCINBrand (NDA)
NDA 050519 · LILLY
- —NEBCINBrand (NDA)
NDA 050477 · LILLY
- 2023TOBRAMYCIN SULFATEGeneric (ANDA)
ANDA 217519 · EUGIA PHARMA
- 2023TOBRAMYCIN SULFATEGeneric (ANDA)
ANDA 217029 · SLATE RUN PHARMA
- 2021TOBRAMYCIN SULFATEGeneric (ANDA)
ANDA 211189 · GLAND
- 2021TOBRAMYCIN SULFATEGeneric (ANDA)
ANDA 209621 · GLAND
- 2021TOBRAMYCIN SULFATE (PHARMACY BULK)Generic (ANDA)
ANDA 209346 · GLAND
- 2016TOBRAMYCIN SULFATEGeneric (ANDA)
ANDA 206965 · BAXTER HLTHCARE CORP
- 2014TOBRAMYCIN SULFATEGeneric (ANDA)
ANDA 205179 · EPIC PHARMA LLC
- 2014TOBRAMYCIN SULFATEGeneric (ANDA)
ANDA 205685 · XELLIA PHARMS APS
- 2008TOBRAMYCIN SULFATEGeneric (ANDA)
ANDA 065407 · MYLAN LABS LTD
- 2002TOBRAMYCIN SULFATEGeneric (ANDA)
ANDA 065122 · FRESENIUS KABI USA
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.
