Drugs@FDA: FDA-Approved Drugs
Company: AUROBINDO PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUCONAZOLE | FLUCONAZOLE | 50MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | No | No |
FLUCONAZOLE | FLUCONAZOLE | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
09/18/2009 | 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 |
---|---|---|---|---|---|
12/27/2023 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
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03/17/2023 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
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01/19/2023 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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01/19/2023 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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01/19/2023 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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01/19/2023 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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01/19/2023 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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01/19/2023 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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01/19/2023 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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02/27/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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02/27/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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02/27/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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01/23/2012 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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01/23/2012 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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12/27/2010 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
FLUCONAZOLE
FOR SUSPENSION;ORAL; 50MG/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DIFLUCAN | FLUCONAZOLE | 50MG/5ML | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 020090 | PFIZER |
FLUCONAZOLE | FLUCONAZOLE | 50MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 079150 | AUROBINDO PHARMA |
FOR SUSPENSION;ORAL; 200MG/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DIFLUCAN | FLUCONAZOLE | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 020090 | PFIZER |
FLUCONAZOLE | FLUCONAZOLE | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 079150 | AUROBINDO PHARMA |
FLUCONAZOLE | FLUCONAZOLE | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 215738 | HAINAN POLY |