Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076145
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% | FLUCONAZOLE | 200MG/100ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% | FLUCONAZOLE | 400MG/200ML (2MG/ML) | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
07/29/2004 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76145ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076145_ORIGINAL APPROVAL_PACKAGE.pdf |
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
INJECTABLE;INJECTION; 200MG/100ML (2MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% | FLUCONAZOLE | 200MG/100ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 076145 | FRESENIUS KABI USA |
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% | FLUCONAZOLE | 200MG/100ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 076087 | HIKMA |
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% | FLUCONAZOLE | 200MG/100ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 076736 | HIKMA FARMACEUTICA |
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE | 200MG/100ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 076766 | BAXTER HLTHCARE |
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE | 200MG/100ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078698 | HIKMA FARMACEUTICA |
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE | 200MG/100ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 076303 | HOSPIRA |
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE | 200MG/100ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 079104 | INFORLIFE |
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE | 200MG/100ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078107 | WEST-WARD PHARMS INT |
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE | 200MG/100ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 077909 | WOODWARD |
INJECTABLE;INJECTION; 400MG/200ML (2MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% | FLUCONAZOLE | 400MG/200ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 076145 | FRESENIUS KABI USA |
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% | FLUCONAZOLE | 400MG/200ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 076087 | HIKMA |
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE | 400MG/200ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 076766 | BAXTER HLTHCARE |
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE | 400MG/200ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078698 | HIKMA FARMACEUTICA |
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE | 400MG/200ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 076303 | HOSPIRA |
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE | 400MG/200ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 079104 | INFORLIFE |
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE | 400MG/200ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078107 | WEST-WARD PHARMS INT |
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE | 400MG/200ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 077909 | WOODWARD |