FDA.reportPublic FDA data

Application 012462

Type
NDA
Sponsor
GD SEARLE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOMOTILATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDETABLET;ORAL0.025MG;2.5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0025-0061Lomotildiphenoxylate hydrochloride and atropine sulfatePfizer Laboratories Div Pfizer IncNDACurrent
0025-0061Lomotildiphenoxylate hydrochloride and atropine sulfateG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-0061Lomotildiphenoxylate hydrochloride and atropine sulfatePfizer Laboratories Div Pfizer IncNDACurrent
0025-0061Lomotildiphenoxylate hydrochloride and atropine sulfatePfizer Laboratories Div Pfizer IncNDACurrent
0025-0061Lomotildiphenoxylate hydrochloride and atropine sulfatePfizer Laboratories Div Pfizer IncNDACurrent
17856-1061Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateAtlantic Biologicals CorpsNDA AUTHORIZED GENERICCurrent
43353-083Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE and ATROPINE SULFATEAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
50090-2641Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-2641Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-2872Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-2872Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
55700-255Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateLake Erie Medical DBA Quality Care Products LLCNDA AUTHORIZED GENERICCurrent
59762-1061Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1061Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateGreenstone LLCNDA AUTHORIZED GENERICCurrent
61919-080DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDirect RxNDA AUTHORIZED GENERICCurrent
67296-1210LomotilLomotilRedPharm Drug, Inc.NDACurrent
67296-1210LomotilLomotilRedPharm Drug, Inc.NDACurrent
67296-1210LomotilLomotilRedPharm Drug, Inc.NDACurrent
67296-1241Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateRedPharm Drug, Inc.NDA AUTHORIZED GENERICCurrent
67296-1241Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateRedPharm Drug, Inc.NDA AUTHORIZED GENERICCurrent
67296-1241Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateRedPharm Drug, Inc.NDA AUTHORIZED GENERICCurrent
70518-2135Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2135Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2135Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2135Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
52638SUPPL2018-02-14
52627SUPPL2018-02-14
49979SUPPL2017-10-06
49965SUPPL2017-10-06
335SUPPL2006-05-02