FDA.reportPublic FDA data

Application 021698

Type
NDA
Sponsor
SANOFI US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZANTAC 150RANITIDINE HYDROCHLORIDETABLET;ORALEQ 150MG BASEYesYes
002ZANTAC 150RANITIDINE HYDROCHLORIDETABLET;ORALEQ 150MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0120Zantac Maximum Strength 150 Cool MintranitidineBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0120Zantac Maximum Strength 150 Cool MintranitidineBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0121Maximum Strength ZantacranitidineBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0121Maximum Strength ZantacranitidineBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
41167-0310Zantac 150Ranitidine HydrochlorideChattem, Inc.NDACurrent
41167-0310Zantac 150Ranitidine HydrochlorideChattem, Inc.NDACurrent
41167-0320Zantac 150Ranitidine HydrochlorideChattem, Inc.NDACurrent
41167-0320Zantac 150Ranitidine HydrochlorideChattem, Inc.NDACurrent
50269-220Zantac 150RANITIDINEJC World Bell Wholesale Co., Inc.NDACurrent
50269-220Zantac 150RANITIDINEJC World Bell Wholesale Co., Inc.NDACurrent
66715-9736Zantac 150RanitidineLil' Drug Store Products, IncNDACurrent
66715-9736Zantac 150RanitidineLil' Drug Store Products, IncNDACurrent
66715-9736Zantac 150RanitidineLil' Drug Store Products, IncNDACurrent
67751-151Zantac 150RANITIDINENavajo Manufacturing Company Inc.NDACurrent
67751-151Zantac 150RANITIDINENavajo Manufacturing Company Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60051SUPPL2019-09-19
60050SUPPL2019-09-19
58243SUPPL2019-04-08
58242SUPPL2019-04-08
45115SUPPL2016-08-26
45062SUPPL2016-08-26
6010SUPPL2016-08-23
45160SUPPL2016-07-27
37477SUPPL2016-03-29
28401SUPPL2016-03-22
16220SUPPL2015-12-22
6009SUPPL2015-12-14
37476SUPPL2015-11-25
28400SUPPL2015-11-23
16219SUPPL2015-03-26
6008SUPPL2015-03-13
21782ORIG2007-06-04
28399SUPPL2007-03-15
37475ORIG2004-09-03
28398ORIG2004-09-03