Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209717
Company: AMNEAL

Products on ANDA 209717

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE;ORAL	Discontinued	None	No	No
ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE;ORAL	Discontinued	None	No	No
ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE;ORAL	Discontinued	None	No	No
ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209717

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/01/2020	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
08/12/2025	SUPPL-9	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
08/12/2025	SUPPL-8	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/12/2025	SUPPL-7	Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
03/26/2024	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.