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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040081
Company: TEVA PHARMS
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
09/30/1994 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
03/30/2023 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

03/08/2022 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

05/11/2020 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

02/20/2008 SUPPL-26 Labeling

Label is not available on this site.

02/05/2003 SUPPL-16 Labeling

Label is not available on this site.

10/08/2002 SUPPL-14 Labeling

Label is not available on this site.

10/08/2002 SUPPL-13 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

10/08/2002 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/08/2002 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

10/31/2001 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

10/31/2001 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

10/31/2001 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

01/23/2002 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

02/26/2001 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

10/10/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/23/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/15/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/09/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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