Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076104
Company: SANDOZ

Products on ANDA 076104

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ITRACONAZOLE	ITRACONAZOLE	100MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076104

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
06/09/2025	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
10/24/2024	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
10/24/2024	SUPPL-25	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
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.
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.
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.

Therapeutic Equivalents for ANDA 076104

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	205724	RISING
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