Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213261
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MICAFUNGIN SODIUM | MICAFUNGIN SODIUM | EQ 50MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | AP | No | No |
MICAFUNGIN SODIUM | MICAFUNGIN SODIUM | EQ 100MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | AP | No | 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 |
---|---|---|---|---|---|---|---|
07/09/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
MICAFUNGIN SODIUM
INJECTABLE;INTRAVENOUS; EQ 50MG BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MICAFUNGIN SODIUM | MICAFUNGIN SODIUM | EQ 50MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 216438 | BIOCON PHARMA |
MICAFUNGIN SODIUM | MICAFUNGIN SODIUM | EQ 50MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 207344 | FRESENIUS KABI USA |
MICAFUNGIN SODIUM | MICAFUNGIN SODIUM | EQ 50MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 213261 | HIKMA |
MICAFUNGIN SODIUM | MICAFUNGIN SODIUM | EQ 50MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 213363 | JIANGSU HANSOH PHARM |
MICAFUNGIN SODIUM | MICAFUNGIN SODIUM | EQ 50MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 215381 | MEITHEAL |
MICAFUNGIN SODIUM | MICAFUNGIN SODIUM | EQ 50MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 211713 | XELLIA PHARMS APS |
MICAFUNGIN SODIUM | MICAFUNGIN SODIUM | EQ 50MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 215241 | ZYDUS PHARMS |
MYCAMINE | MICAFUNGIN SODIUM | EQ 50MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 021506 | ASTELLAS |
INJECTABLE;INTRAVENOUS; EQ 100MG BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MICAFUNGIN SODIUM | MICAFUNGIN SODIUM | EQ 100MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 216438 | BIOCON PHARMA |
MICAFUNGIN SODIUM | MICAFUNGIN SODIUM | EQ 100MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 207344 | FRESENIUS KABI USA |
MICAFUNGIN SODIUM | MICAFUNGIN SODIUM | EQ 100MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 213261 | HIKMA |
MICAFUNGIN SODIUM | MICAFUNGIN SODIUM | EQ 100MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 213363 | JIANGSU HANSOH PHARM |
MICAFUNGIN SODIUM | MICAFUNGIN SODIUM | EQ 100MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 215381 | MEITHEAL |
MICAFUNGIN SODIUM | MICAFUNGIN SODIUM | EQ 100MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 211713 | XELLIA PHARMS APS |
MICAFUNGIN SODIUM | MICAFUNGIN SODIUM | EQ 100MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 215241 | ZYDUS PHARMS |
MYCAMINE | MICAFUNGIN SODIUM | EQ 100MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 021506 | ASTELLAS |