Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070288
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CONSTULOSE LACTULOSE 10GM/15ML SOLUTION;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
08/15/1988 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
12/16/1997 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/26/1996 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/17/1996 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

09/09/1994 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/04/1993 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/03/1993 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/04/1993 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/24/1991 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/11/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/21/1991 SUPPL-15 Labeling

Label is not available on this site.

09/28/1990 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/27/1992 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/31/1990 SUPPL-12 Labeling

Label is not available on this site.

08/21/1991 SUPPL-9 Labeling

Label is not available on this site.

08/19/1988 SUPPL-1 Labeling

Label is not available on this site.

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