Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084914
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUINIDINE SULFATE QUINIDINE 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
08/18/1977 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
06/10/1996 SUPPL-30 Labeling

Label is not available on this site.

04/26/1995 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

03/24/1989 SUPPL-28 Labeling

Label is not available on this site.

12/20/1988 SUPPL-27 Labeling

Label is not available on this site.

03/12/1985 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

06/01/1984 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

06/01/1984 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

11/08/1983 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/22/1983 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

09/30/1982 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/10/1982 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/10/1982 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/10/1982 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/10/1982 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/10/1982 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/10/1982 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

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