Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017884
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHRONULAC LACTULOSE 10GM/15ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;ORAL Discontinued None Yes No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
06/20/1979 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
02/02/1993 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/1992 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/22/1990 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

12/09/1988 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/16/1989 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/27/1988 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1988 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/09/1987 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/28/1984 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1983 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1981 SUPPL-10 Labeling

Label is not available on this site.

10/22/1981 SUPPL-9 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/03/1980 SUPPL-8 Labeling

Label is not available on this site.

07/07/1980 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/28/1979 SUPPL-6 Labeling

Label is not available on this site.

03/04/1980 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

12/28/1979 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/29/1980 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/28/1979 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/28/1979 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

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