Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204040
Company: AVET LIFESCIENCES
Company: AVET LIFESCIENCES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMIKACIN SULFATE | AMIKACIN SULFATE | EQ 250MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/12/2013 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/10/2023 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
12/13/2019 | SUPPL-14 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
12/13/2019 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
12/13/2019 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
06/14/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
AMIKACIN SULFATE
INJECTABLE;INJECTION; EQ 250MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMIKACIN SULFATE | AMIKACIN SULFATE | EQ 250MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204040 | AVET LIFESCIENCES |
AMIKACIN SULFATE | AMIKACIN SULFATE | EQ 250MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205604 | FRESENIUS KABI USA |
AMIKACIN SULFATE | AMIKACIN SULFATE | EQ 250MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 063315 | HIKMA |
AMIKACIN SULFATE | AMIKACIN SULFATE | EQ 250MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 064045 | MEITHEAL |
AMIKACIN SULFATE | AMIKACIN SULFATE | EQ 250MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 218146 | QILU |
AMIKACIN SULFATE | AMIKACIN SULFATE | EQ 250MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203323 | SAGENT PHARMS INC |