Orange Book product · Brand (NDA)
KITABIS PAK
TOBRAMYCIN
At a glance
Dec 02, 2014
Approved
Brand (NDA)
Application
AN
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 02, 2014
11 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
TOBRAMYCIN
Strength
300MG/5ML
Dosage form
SOLUTION
Route
INHALATION
TE code
AN
Application
NDA 205433
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.
- 2013TOBI PODHALERBrand (NDA)
NDA 201688 · VIATRIS
- 2012BETHKISBrand (NDA)
NDA 201820 · CHIESI
- 1997TOBIBrand (NDA)
NDA 050753 · VIATRIS
- —TOBREXBrand (NDA)
NDA 050555 · NOVARTIS
- —TOBREXBrand (NDA)
NDA 050541 · NOVARTIS
- 2023TOBRAMYCINGeneric (ANDA)
ANDA 217344 · MICRO LABS
- 2023TOBRAMYCINGeneric (ANDA)
ANDA 214478 · MANKIND PHARMA
- 2022TOBRAMYCINGeneric (ANDA)
ANDA 216725 · MANKIND PHARMA
- 2021TOBRAMYCINGeneric (ANDA)
ANDA 212848 · ALKEM LABS LTD
- 2021TOBRAMYCINGeneric (ANDA)
ANDA 212628 · GLAND
- 2021TOBRAMYCINGeneric (ANDA)
ANDA 210871 · LUOXIN AUROVITAS
- 2019TOBRAMYCINGeneric (ANDA)
ANDA 207136 · SUN PHARM
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.
