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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208591
Company: ALKEM LABS LTD

Products on ANDA 208591

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 208591

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
03/12/2025	SUPPL-14	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
03/12/2025	SUPPL-13	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
06/10/2024	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
05/04/2023	SUPPL-9	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
10/11/2019	SUPPL-4	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
10/11/2019	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
10/11/2019	SUPPL-2	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 208591

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

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