Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208591
Company: ALKEM LABS LTD
Company: ALKEM LABS LTD
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 |
---|---|---|---|---|---|---|---|
06/12/2017 | 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 |
---|---|---|---|---|---|
06/10/2024 | SUPPL-10 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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05/04/2023 | SUPPL-9 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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10/11/2019 | SUPPL-4 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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10/11/2019 | SUPPL-3 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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10/11/2019 | SUPPL-2 | Labeling-Package Insert, Labeling-Medication Guide |
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 |