Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204672
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
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 |
---|---|---|---|---|---|---|---|
09/19/2017 | 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 |
---|---|---|---|---|---|
10/04/2019 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
10/04/2019 | SUPPL-2 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
10/04/2019 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert |
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 | 205991 | ACCORD HLTHCARE |
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 |