Orange Book product · Generic (ANDA)
AMIKACIN SULFATE
AMIKACIN SULFATE
At a glance
Mar 19, 2024
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 19, 2024
2 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
AMIKACIN SULFATE
Strength
EQ 250MG BASE/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 218146
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of AMIKACIN SULFATE
- 2018ARIKAYCE KITBrand (NDA)
NDA 207356 · INSMED INC
- 1987AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 050618 · APOTHECON
- —AMIKINBrand (NDA)
NDA 050495 · APOTHECON
- 2016AMIKACIN SULFATEGeneric (ANDA)
ANDA 203323 · SAGENT PHARMS INC
- 2015AMIKACIN SULFATEGeneric (ANDA)
ANDA 205605 · FRESENIUS KABI USA
- 2015AMIKACIN SULFATEGeneric (ANDA)
ANDA 205604 · FRESENIUS KABI USA
- 2013AMIKACIN SULFATEGeneric (ANDA)
ANDA 204040 · AVET LIFESCIENCES
- 1997AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 064146 · HOSPIRA
- 1995AMIKACIN SULFATEGeneric (ANDA)
ANDA 063167 · IGI LABS INC
- 1995AMIKACIN SULFATEGeneric (ANDA)
ANDA 063169 · IGI LABS INC
- 1995AMIKACIN SULFATEGeneric (ANDA)
ANDA 064098 · HOSPIRA
- 1995AMIKACIN SULFATEGeneric (ANDA)
ANDA 064099 · HOSPIRA
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.
