Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085311
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LONOX ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG;2.5MG TABLET;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
06/07/1977 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
11/28/2000 SUPPL-72 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/2000 SUPPL-71 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1999 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

11/23/1998 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

08/04/1999 SUPPL-67 Labeling

Label is not available on this site.

08/04/1999 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

06/08/1998 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

01/29/1998 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

06/26/1991 SUPPL-63 Labeling

Label is not available on this site.

12/19/1989 SUPPL-62 Labeling

Label is not available on this site.

08/09/1989 SUPPL-61 Labeling

Label is not available on this site.

12/09/1988 SUPPL-60 Labeling

Label is not available on this site.

04/19/1988 SUPPL-59 Labeling

Label is not available on this site.

01/23/1985 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

10/28/1985 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

06/17/1983 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

04/22/1983 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

04/22/1983 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

11/16/1982 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

10/15/1982 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

07/29/1982 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

07/29/1982 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

05/13/1982 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

05/13/1982 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

05/13/1982 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

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