Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016640
Company: BRISTOL MYERS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUESTRAN CHOLESTYRAMINE EQ 4GM RESIN/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** POWDER;ORAL Discontinued None Yes No
QUESTRAN CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** POWDER;ORAL Discontinued None Yes No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
08/03/1973 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/22/1997 SUPPL-74 Labeling

Label is not available on this site.

12/12/1994 SUPPL-71 Labeling

Label is not available on this site.

12/12/1994 SUPPL-70 Labeling

Label is not available on this site.

09/22/1995 SUPPL-69 Labeling

Label is not available on this site.

09/22/1995 SUPPL-68 Labeling

Label is not available on this site.

01/07/1993 SUPPL-67 Manufacturing (CMC)-Control

Label is not available on this site.

08/11/1992 SUPPL-66 Labeling

Label is not available on this site.

09/22/1992 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

09/10/1991 SUPPL-63 Labeling

Label is not available on this site.

10/24/1991 SUPPL-60 Labeling

Label is not available on this site.

05/25/1990 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

03/05/1990 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1991 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/1990 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

11/28/1989 SUPPL-55 Labeling

Label is not available on this site.

01/22/1990 SUPPL-54 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/23/1989 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

12/01/1988 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

10/11/1988 SUPPL-48 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/26/1988 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

08/26/1988 SUPPL-46 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/14/1988 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

07/14/1988 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

07/14/1988 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

03/02/1989 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

06/29/1988 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

03/25/1988 SUPPL-39 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/18/1988 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

01/05/1988 SUPPL-37 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/16/1988 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

11/19/1987 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

11/19/1987 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1994 SUPPL-33 Labeling

Label is not available on this site.

09/18/1987 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

01/24/1986 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1986 SUPPL-27 Labeling

Label is not available on this site.

09/19/1986 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

03/12/1986 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/1985 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/1985 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/01/1985 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/1984 SUPPL-21 Labeling

Label is not available on this site.

05/11/1984 SUPPL-17 Labeling

Label is not available on this site.

06/14/1984 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1983 SUPPL-14 Labeling

Label is not available on this site.

06/24/1983 SUPPL-13 Labeling

Label is not available on this site.

08/16/1982 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1982 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/1982 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/08/1981 SUPPL-9 Labeling

Label is not available on this site.

02/17/1977 SUPPL-5 Labeling

Label is not available on this site.

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