Orange Book product · Generic (ANDA)
AMIKACIN SULFATE
AMIKACIN SULFATE
At a glance
Nov 30, 1994
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 30, 1994
32 yr ago
Today
Pharmaceutical detail
Active ingredient
AMIKACIN SULFATE
Strength
EQ 50MG BASE/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 063263
Product number
001
Marketing status
DISCN
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
- 2024AMIKACIN SULFATEGeneric (ANDA)
ANDA 218146 · QILU
- 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
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.
