Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076087
Company: HIKMA
Company: HIKMA
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 | 100MG/50ML (2MG/ML) | INJECTABLE;INJECTION | Prescription | None | 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/2004/76087ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076087_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/27/2020 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
11/27/2020 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
03/14/2012 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
01/30/2012 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
01/30/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
12/01/2008 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
09/26/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |
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 |