FDA.reportPublic FDA data

Application 201921

Type
ANDA
Sponsor
NATCO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LANSOPRAZOLELANSOPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL15MGNoNo
002LANSOPRAZOLELANSOPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16571-697LANSOPRAZOLELANSOPRAZOLERising Pharma Holdings, Inc.ANDACurrent
16571-698LANSOPRAZOLELANSOPRAZOLERising Pharma Holdings, Inc.ANDACurrent
45963-460LansoprazoleLansoprazoleACTAVIS PHARMA, INC.ANDACurrent
45963-460LansoprazoleLansoprazoleACTAVIS PHARMA, INC.ANDACurrent
45963-460LansoprazoleLansoprazoleACTAVIS PHARMA, INC.ANDACurrent
50090-2225LANSOPRAZOLELANSOPRAZOLEA-S Medication SolutionsANDACurrent
50090-2225LANSOPRAZOLELANSOPRAZOLEA-S Medication SolutionsANDACurrent
50090-2739LANSOPRAZOLELANSOPRAZOLEA-S Medication SolutionsANDACurrent
51991-771LANSOPRAZOLELANSOPRAZOLEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-771LANSOPRAZOLELANSOPRAZOLEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-771LANSOPRAZOLELANSOPRAZOLEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-772LANSOPRAZOLELANSOPRAZOLEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-772LANSOPRAZOLELANSOPRAZOLEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-772LANSOPRAZOLELANSOPRAZOLEBreckenridge Pharmaceutical, Inc.ANDACurrent
55700-393LANSOPRAZOLELANSOPRAZOLELake Erie Medical DBA Quality Care Products LLCANDACurrent
68788-9406LansoprazoleLansoprazolePreferred Pharmaceuticals, Inc.ANDACurrent
69336-107LANSOPRAZOLELANSOPRAZOLESterling Knight Pharmaceuticals LLCANDACurrent
70934-369LANSOPRAZOLELANSOPRAZOLEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-369LANSOPRAZOLELANSOPRAZOLEDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent