Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203323
Company: SAGENT PHARMS INC
Company: SAGENT PHARMS INC
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 | No |
AMIKACIN SULFATE | AMIKACIN SULFATE | 500MG(BASE)/ML(250MG/ML) | INJECTABLE;INJECTION | Prescription | None | TBD | No |
AMIKACIN SULFATE | AMIKACIN SULFATE | 1G(BASE)/4ML(250MG/ML) | INJECTABLE;INJECTION | Prescription | None | TBD | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/12/2016 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/12/2016 | SUPPL-12 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
02/10/2023 | SUPPL-7 | 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 |