Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205573
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ITRACONAZOLE | ITRACONAZOLE | 10MG/ML | SOLUTION;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
10/30/2015 | 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 |
---|---|---|---|---|---|
03/16/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
03/16/2020 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
03/16/2020 | SUPPL-2 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
ITRACONAZOLE
SOLUTION;ORAL; 10MG/ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ITRACONAZOLE | ITRACONAZOLE | 10MG/ML | SOLUTION;ORAL | Prescription | No | AA | 205573 | AMNEAL PHARMS |
ITRACONAZOLE | ITRACONAZOLE | 10MG/ML | SOLUTION;ORAL | Prescription | No | AA | 212239 | ANNORA PHARMA |
SPORANOX | ITRACONAZOLE | 10MG/ML | SOLUTION;ORAL | Prescription | Yes | AA | 020657 | JANSSEN PHARMS |