Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087810
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUINIDINE GLUCONATE QUINIDINE GLUCONATE 324MG TABLET, EXTENDED RELEASE;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
09/29/1982 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
01/08/2001 SUPPL-21 Labeling

Label is not available on this site.

04/30/1999 SUPPL-20 Labeling

Label is not available on this site.

10/08/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/16/1996 SUPPL-17 Labeling

Label is not available on this site.

04/14/1992 SUPPL-13 Labeling

Label is not available on this site.

01/10/1992 SUPPL-12 Labeling

Label is not available on this site.

07/02/1991 SUPPL-11 Labeling

Label is not available on this site.

08/12/1991 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/28/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/17/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/18/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/08/1983 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/01/1982 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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