Orange Book product · Brand (NDA)
NEBCIN
TOBRAMYCIN SULFATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
TOBRAMYCIN SULFATE
Strength
EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 050477
Product number
005
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2004TOBRAMYCIN SULFATEBrand (NDA)
NDA 050789 · FRESENIUS KABI USA
- —NEBCINBrand (NDA)
NDA 050519 · 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.
