Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085583
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUINIDINE SULFATE QUINIDINE SULFATE 300MG 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
06/09/1981 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
04/25/2001 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

03/09/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

11/20/1997 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

06/10/1996 SUPPL-23 Labeling

Label is not available on this site.

09/15/1994 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/04/1989 SUPPL-17 Labeling

Label is not available on this site.

01/09/1989 SUPPL-16 Labeling

Label is not available on this site.

07/21/1988 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/21/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/09/1985 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/01/1985 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/01/1985 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/12/1985 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

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