Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040760
Company: HIKMA PHARMS

Products on ANDA 040760

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040760

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/15/2007	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
03/21/2024	SUPPL-11	Labeling, Labeling-Package Insert		Label is not available on this site.
03/21/2024	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
07/18/2022	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
10/20/2021	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
04/28/2020	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
04/01/2020	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040760Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/040760Orig1s006ltr.pdf

Labels for ANDA 040760

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/01/2020	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040760Orig1s006lbl.pdf