Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206799
Company: NOVEL LABS INC
Company: NOVEL LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VORICONAZOLE | VORICONAZOLE | 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 |
---|---|---|---|---|---|---|---|
05/31/2016 | 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 |
---|---|---|---|---|---|
05/20/2024 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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02/14/2024 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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02/14/2024 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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02/14/2024 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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02/14/2024 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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02/14/2024 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
VORICONAZOLE
FOR SUSPENSION;ORAL; 200MG/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VFEND | VORICONAZOLE | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 021630 | PF PRISM CV |
VORICONAZOLE | VORICONAZOLE | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 205034 | AMNEAL PHARMS |
VORICONAZOLE | VORICONAZOLE | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 216805 | HAINAN POLY |
VORICONAZOLE | VORICONAZOLE | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 206799 | NOVEL LABS INC |