FDA.reportPublic FDA data

Application 021855

Type
NDA
Sponsor
BIONPHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDECAPSULE;ORAL1MGYesNo
002LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDECAPSULE;ORAL2MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWalgreensNDACurrent
0363-0520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWalgreensNDACurrent
0363-1176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWALGREENSNDACurrent
0363-1176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWALGREENSNDACurrent
0363-1176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWALGREENSNDACurrent
0363-1176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWALGREENSNDACurrent
0363-1176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWALGREENSNDACurrent
0363-1176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWALGREENSNDACurrent
11673-177Anti-DiarrhealLOPERAMIDE HYDROCHLORIDETARGET CorporationNDACurrent
11673-177Anti-DiarrhealLOPERAMIDE HYDROCHLORIDETARGET CorporationNDACurrent
11673-520Loperamide HClLOPERAMIDE HYDROCHLORIDETARGET CorporationNDACurrent
11673-520Loperamide HClLOPERAMIDE HYDROCHLORIDETARGET CorporationNDACurrent
11822-7834Anti-DiarrhealLOPERAMIDE HYDROCHLORIDERite Aid CorporationNDACurrent
11822-7834Anti-DiarrhealLOPERAMIDE HYDROCHLORIDERite Aid CorporationNDACurrent
30142-159Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEKROGER COMPANYNDACurrent
30142-159Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEKROGER COMPANYNDACurrent
30142-159Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEKROGER COMPANYNDACurrent
30142-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEThe Kroger Co.NDACurrent
30142-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEThe Kroger Co.NDACurrent
30142-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEThe Kroger Co.NDACurrent
33992-0520Anti-DiarrhealLoperamide HClASSURED / DOLLAR TREE (Greenbrier International, Inc.)NDACurrent
33992-0520Anti-DiarrhealLoperamide HClASSURED / DOLLAR TREE (Greenbrier International, Inc.)NDACurrent
33992-0820Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEASSURED / DOLLAR TREE (Greenbrier International, Inc.)NDACurrent
33992-0820Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEASSURED / DOLLAR TREE (Greenbrier International, Inc.)NDACurrent
33992-0820Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEASSURED / DOLLAR TREE (Greenbrier International, Inc.)NDACurrent
33992-0820Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEASSURED / DOLLAR TREE (Greenbrier International, Inc.)NDACurrent
36800-208Anti-DiarrhealLOPERAMIDE HYDROCHLORIDETOP CARE (Topco Associates LLC)NDACurrent
36800-208Anti-DiarrhealLOPERAMIDE HYDROCHLORIDETOP CARE (Topco Associates LLC)NDACurrent
36800-520Anti-Diarrheal Loperamide HClLOPERAMIDE HYDROCHLORIDETOP CARE (Topco Associates LLC)NDACurrent
36800-520Anti-Diarrheal Loperamide HClLOPERAMIDE HYDROCHLORIDETOP CARE (Topco Associates LLC)NDACurrent
37808-988Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEHEBNDACurrent
37808-988Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEHEBNDACurrent
37808-988Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEHEBNDACurrent
41250-210anti-diarrhealLOPERAMIDE HYDROCHLORIDEMEIJER DISTRIBUTION INCNDACurrent
41250-210anti-diarrhealLOPERAMIDE HYDROCHLORIDEMEIJER DISTRIBUTION INCNDACurrent
41250-210anti-diarrhealLOPERAMIDE HYDROCHLORIDEMEIJER DISTRIBUTION INCNDACurrent
41250-210anti-diarrhealLOPERAMIDE HYDROCHLORIDEMEIJER DISTRIBUTION INCNDACurrent
41250-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEMEIJER, INC.NDACurrent
41250-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEMEIJER, INC.NDACurrent
41250-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEMEIJER, INC.NDACurrent
41520-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECare One (American Sales Company)NDACurrent
41520-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECare One (American Sales Company)NDACurrent
41520-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECare One (American Sales Company)NDACurrent
42507-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEHy-VeeNDACurrent
42507-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEHy-VeeNDACurrent
42507-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEHy-VeeNDACurrent
46122-207Anti-DiarrhealLoperamide HClAmerisourceBergen (Good Neighbor Pharmacy) 46122NDACurrent
46122-207Anti-DiarrhealLoperamide HClAmerisourceBergen (Good Neighbor Pharmacy) 46122NDACurrent
46122-581Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEAMERISOURCE BERGENNDACurrent
46122-581Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEAMERISOURCE BERGENNDACurrent
46122-581Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEAMERISOURCE BERGENNDACurrent
49035-483Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWal-Mart Stores, Inc.NDACurrent
49035-483Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWal-Mart Stores, Inc.NDACurrent
49035-483Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWal-Mart Stores, Inc.NDACurrent
49035-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEEQUATE (Wal-Mart Stores, Inc.)NDACurrent
49035-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEEQUATE (Wal-Mart Stores, Inc.)NDACurrent
49035-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEEQUATE (Wal-Mart Stores, Inc.)NDACurrent
49348-752Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEStrategic Sourcing Services LLCNDACurrent
49348-752Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEMcKesson (Sunmark)NDACurrent
50580-367Imodium A-DLoperamide HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-367Imodium A-DLoperamide HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-367Imodium A-DLoperamide HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-367Imodium A-DLoperamide HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50804-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEGood Sense (Geiss, Destin & Dunn, Inc.)NDACurrent
50804-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEGood Sense (Geiss, Destin & Dunn, Inc.)NDACurrent
53943-176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDISCOUNT DRUG MART, INC.NDACurrent
53943-176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDISCOUNT DRUG MART, INC.NDACurrent
53943-176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDISCOUNT DRUG MART, INC.NDACurrent
55312-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWestern Family Foods, Inc.NDACurrent
55315-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEFreds IncNDACurrent
55910-176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDOLGENCORP, LLCNDACurrent
55910-176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDOLGENCORP, LLCNDACurrent
55910-176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDOLGENCORP, LLCNDACurrent
55910-176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDOLGENCORP, LLCNDACurrent
55910-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)NDACurrent
55910-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)NDACurrent
55910-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)NDACurrent
59726-520Loperamide HCl Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEP & L Development, LLCNDACurrent
59779-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECVS PharmacyNDACurrent
59779-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECVS PharmacyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63686SUPPL2020-06-24
59327SUPPL2019-07-15
59326SUPPL2019-07-15
47567SUPPL2017-03-16
47547SUPPL2017-03-14
21843ORIG2007-06-04
37765ORIG2005-08-08
6309ORIG2005-08-08