Orange Book product · Brand (NDA)
AMIKIN
AMIKACIN 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
AMIKACIN SULFATE
Strength
EQ 250MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 050495
Product number
002
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.
- 2018ARIKAYCE KITBrand (NDA)
NDA 207356 · INSMED INC
- 1987AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 050618 · 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
- 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.
