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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040133
Company: WATSON LABS

Products on ANDA 040133

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 040133

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/30/1995	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
04/06/2022	SUPPL-31	Labeling-Package Insert		Label is not available on this site.
04/01/2020	SUPPL-30	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040133Orig1s029, s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/040133Orig1s029, s030ltr.pdf
04/01/2020	SUPPL-29	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040133Orig1s029, s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/040133Orig1s029, s030ltr.pdf
11/21/2003	SUPPL-13	Labeling		Label is not available on this site.
04/12/2001	SUPPL-9	Manufacturing (CMC)-Facility		Label is not available on this site.
03/21/2000	SUPPL-7	Manufacturing (CMC)-Facility		Label is not available on this site.
08/19/1998	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
02/23/1998	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/23/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
07/08/1997	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
10/07/1997	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 040133

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/01/2020	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040133Orig1s029, s030lbl.pdf
04/01/2020	SUPPL-29	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040133Orig1s029, s030lbl.pdf
04/01/2020	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040133Orig1s029, s030lbl.pdf

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