Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089338
Company: SUN PHARM INDS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUINIDINE GLUCONATE QUINIDINE GLUCONATE 324MG TABLET, EXTENDED RELEASE;ORAL Prescription BX No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/11/1987 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
02/02/2010 SUPPL-36 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/089338s036lbl.pdf
03/31/2003 SUPPL-24 Labeling

Label is not available on this site.

07/10/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2000 SUPPL-19 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

07/17/2000 SUPPL-17 Labeling

Label is not available on this site.

06/04/2001 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/04/1999 SUPPL-15 Labeling

Label is not available on this site.

12/05/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/06/1996 SUPPL-12 Labeling

Label is not available on this site.

06/22/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/25/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/31/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/12/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/15/1993 SUPPL-7 Labeling

Label is not available on this site.

07/16/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/08/1990 SUPPL-5 Labeling

Label is not available on this site.

01/12/1990 SUPPL-4 Labeling

Label is not available on this site.

07/17/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/17/1987 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
02/02/2010 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/089338s036lbl.pdf

QUINIDINE GLUCONATE

There are no Therapeutic Equivalents.

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