Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012796
Company: WYETH PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUINIDEX QUINIDINE SULFATE 300MG 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
02/21/1962 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/16/2001 SUPPL-49 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/12796s49lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12796s49ltr.pdf
06/24/1998 SUPPL-48 Labeling

Label is not available on this site.

01/13/1998 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

11/09/1995 SUPPL-46 Labeling

Label is not available on this site.

05/02/1988 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/25/1988 SUPPL-43 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/01/1987 SUPPL-42 Labeling

Label is not available on this site.

06/12/1987 SUPPL-41 Labeling

Label is not available on this site.

04/22/1986 SUPPL-40 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/12/1986 SUPPL-39 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/02/1988 SUPPL-38 Labeling

Label is not available on this site.

07/22/1985 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/07/1985 SUPPL-36 Labeling

Label is not available on this site.

07/22/1985 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1984 SUPPL-34 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/31/1984 SUPPL-33 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/04/1984 SUPPL-32 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/04/1984 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/04/1984 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/07/2007 SUPPL-29 Labeling

Label is not available on this site.

10/26/1982 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/08/1982 SUPPL-27 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/07/2007 SUPPL-24 Labeling

Label is not available on this site.

12/04/1981 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/04/1981 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/22/1984 SUPPL-21 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/19/1980 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/19/1980 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

06/21/1979 SUPPL-18 Labeling

Label is not available on this site.

12/19/1980 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1978 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/20/1978 SUPPL-15 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/11/1977 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

10/11/1977 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

10/11/1977 SUPPL-12 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/11/1977 SUPPL-11 Efficacy

Label is not available on this site.

10/11/1977 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-8 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/16/2001 SUPPL-49 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/12796s49lbl.pdf

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