Drugs@FDA: FDA-Approved Drugs
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. |