FDA.reportPublic FDA data

Application 207891

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLEOMEPRAZOLETABLET, DELAYED RELEASE;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
30142-992omeprazoleomeprazoleTHE KROGER COMPANYANDACurrent
30142-992omeprazoleomeprazoleTHE KROGER COMPANYANDACurrent
37835-001OmeprazoleOmeprazoleBI-MARTANDACurrent
51660-029OmeprazoleOmeprazoleOHM LABORATORIES INC.ANDACurrent
51660-029OmeprazoleOmeprazoleOHM LABORATORIES INC.ANDACurrent
51660-029OmeprazoleOmeprazoleOHM LABORATORIES INC.ANDACurrent
51660-029OmeprazoleOmeprazoleOHM LABORATORIES INC.ANDACurrent
51660-029OmeprazoleOmeprazoleOHM LABORATORIES INC.ANDACurrent
51660-029OmeprazoleOmeprazoleOHM LABORATORIES INC.ANDACurrent
55681-306OmeprazoleOMEPRAZOLETwin Med LLCANDACurrent
55681-306OmeprazoleOMEPRAZOLETwin Med LLCANDACurrent
57483-840omeprazoleomeprazoleINNOVUS PHARMACEUTICALS, INC.ANDACurrent
62756-377OmeprazoleOmeprazoleSun Pharmaceutical Industries, Inc.ANDACurrent
62756-377OmeprazoleOmeprazoleSun Pharmaceutical Industries, Inc.ANDACurrent
62756-377OmeprazoleOmeprazoleSun Pharmaceutical Industries, Inc.ANDACurrent
70677-0148OmeprazoleOmeprazoleStrategic Sourcing ServicesANDACurrent
72036-981OmeprazoleOMEPRAZOLEHARRIS TEETERANDACurrent
72036-981OmeprazoleOMEPRAZOLEHARRIS TEETERANDACurrent
72559-014omeprazoleomeprazoleLittle Pharma, Inc.ANDACurrent
72559-014omeprazoleomeprazoleLittle Pharma, Inc.ANDACurrent
72559-014omeprazoleomeprazoleLittle Pharma, Inc.ANDACurrent
72559-014omeprazoleomeprazoleLittle Pharma, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56473ORIG2018-11-15