Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017657
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEPHULAC LACTULOSE 10GM/15ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;ORAL, RECTAL Discontinued None Yes No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
03/25/1976 ORIG-1 Approval Type 1 - New Molecular Entity 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
02/09/1993 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/1992 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

04/05/1991 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/22/1990 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

12/09/1988 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/16/1989 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/18/1987 SUPPL-25 Labeling

Label is not available on this site.

05/27/1988 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1988 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/09/1987 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

05/31/1984 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

01/14/1983 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1981 SUPPL-18 Labeling

Label is not available on this site.

10/22/1981 SUPPL-17 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/13/1980 SUPPL-16 Labeling

Label is not available on this site.

10/03/1980 SUPPL-15 Labeling

Label is not available on this site.

08/20/1980 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/20/1980 SUPPL-13 Labeling

Label is not available on this site.

03/04/1980 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

12/27/1979 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1980 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/21/1978 SUPPL-8 Labeling

Label is not available on this site.

05/04/1979 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/08/1977 SUPPL-6 Labeling

Label is not available on this site.

12/08/1977 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/03/1977 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/12/1977 SUPPL-3 Labeling

Label is not available on this site.

05/12/1977 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/27/1980 SUPPL-1 Efficacy

Label is not available on this site.

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