Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012699
Company: GD SEARLE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOMOTIL ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG/5ML;2.5MG/5ML 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
10/19/1961 ORIG-1 Approval Type 3 - New Dosage Form 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
04/28/2006 SUPPL-36 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/012462s042, 012699s036LTR.pdf
02/18/1994 SUPPL-35 Labeling

Label is not available on this site.

04/23/1991 SUPPL-34 Labeling

Label is not available on this site.

03/12/1987 SUPPL-33 Labeling

Label is not available on this site.

04/07/1986 SUPPL-32 Labeling

Label is not available on this site.

03/01/1984 SUPPL-31 Labeling

Label is not available on this site.

12/21/1983 SUPPL-30 Labeling

Label is not available on this site.

04/28/1983 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1982 SUPPL-26 Labeling

Label is not available on this site.

11/05/1979 SUPPL-25 Labeling

Label is not available on this site.

03/01/1977 SUPPL-24 Labeling

Label is not available on this site.

11/22/1976 SUPPL-23 Labeling

Label is not available on this site.

07/28/1976 SUPPL-21 Labeling

Label is not available on this site.

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