Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040150
Company: INVATECH
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/27/1996 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
04/01/2020 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040150Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/040150Orig1s007ltr.pdf
03/20/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

03/20/2001 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/09/2000 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/04/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/10/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/10/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/01/2020 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040150Orig1s007lbl.pdf

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