Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012462
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;2.5MG TABLET;ORAL Prescription AA Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/15/1960 ORIG-1 Approval Type 4 - New Combination 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
02/12/2018 SUPPL-48 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012462s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012462Orig1s048ltr.pdf
10/05/2017 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012462s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/012462Orig1s045ltr.pdf
04/28/2006 SUPPL-42 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/012462s042, 012699s036LTR.pdf
06/07/1996 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

02/18/1994 SUPPL-40 Labeling

Label is not available on this site.

04/23/1991 SUPPL-39 Labeling

Label is not available on this site.

03/12/1987 SUPPL-38 Labeling

Label is not available on this site.

06/04/1986 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

04/07/1986 SUPPL-36 Labeling

Label is not available on this site.

03/01/1984 SUPPL-35 Labeling

Label is not available on this site.

12/21/1983 SUPPL-34 Labeling

Label is not available on this site.

04/07/1983 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1982 SUPPL-31 Labeling

Label is not available on this site.

12/30/1980 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/08/1981 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/22/1979 SUPPL-28 Labeling

Label is not available on this site.

11/05/1979 SUPPL-27 Labeling

Label is not available on this site.

02/28/1977 SUPPL-26 Labeling

Label is not available on this site.

02/28/1977 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/12/2018 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012462s048lbl.pdf
02/12/2018 SUPPL-48 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012462s048lbl.pdf
10/05/2017 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012462s045lbl.pdf

LOMOTIL

TABLET;ORAL; 0.025MG;2.5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG;2.5MG TABLET;ORAL Prescription No AA 086727 ANI PHARMS INC
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG;2.5MG TABLET;ORAL Prescription No AA 210819 BAYSHORE PHARMS LLC
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG;2.5MG TABLET;ORAL Prescription No AA 085372 LANNETT
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG;2.5MG TABLET;ORAL Prescription No AA 085762 MYLAN
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG;2.5MG TABLET;ORAL Prescription No AA 040357 PAR PHARM
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG;2.5MG TABLET;ORAL Prescription No AA 210571 UPSHER SMITH LABS
LOMOTIL ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG;2.5MG TABLET;ORAL Prescription Yes AA 012462 GD SEARLE LLC

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