Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ITRACONAZOLE | ITRACONAZOLE | 100MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
05/28/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76104ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/26/2023 | SUPPL-24 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
10/09/2019 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
10/09/2019 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
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10/09/2019 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
10/09/2019 | SUPPL-19 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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11/17/2015 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
11/17/2015 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
02/20/2013 | SUPPL-11 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
03/29/2012 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
01/12/2011 | SUPPL-9 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
ITRACONAZOLE
CAPSULE;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ITRACONAZOLE | ITRACONAZOLE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 206741 | ALEMBIC |
ITRACONAZOLE | ITRACONAZOLE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 208591 | ALKEM LABS LTD |
ITRACONAZOLE | ITRACONAZOLE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 205080 | AMNEAL PHARMS |
ITRACONAZOLE | ITRACONAZOLE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 076104 | SANDOZ |
ITRACONAZOLE | ITRACONAZOLE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 209460 | TORRENT |
ITRACONAZOLE | ITRACONAZOLE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 204672 | ZYDUS PHARMS |
SPORANOX | ITRACONAZOLE | 100MG | CAPSULE;ORAL | Prescription | Yes | AB | 020083 | JANSSEN PHARMS |