FDA.reportPublic FDA data

Application 210610

Type
ANDA
Sponsor
UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MORPHINE SULFATEMORPHINE SULFATETABLET;ORAL15MGNoNo
002MORPHINE SULFATEMORPHINE SULFATETABLET;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0832-0273Morphine Sulfatemorphine sulfateUpsher-Smith Laboratories, LLCANDACurrent
0832-0273Morphine Sulfatemorphine sulfateUpsher-Smith Laboratories, LLCANDACurrent
0832-0273Morphine Sulfatemorphine sulfateUpsher-Smith Laboratories, LLCANDACurrent
0832-0273Morphine Sulfatemorphine sulfateUpsher-Smith Laboratories, LLCANDACurrent
0832-0273Morphine Sulfatemorphine sulfateUpsher-Smith Laboratories, LLCANDACurrent
0832-0274Morphine Sulfatemorphine sulfateUpsher-Smith Laboratories, LLCANDACurrent
0832-0274Morphine Sulfatemorphine sulfateUpsher-Smith Laboratories, LLCANDACurrent
0832-0274Morphine Sulfatemorphine sulfateUpsher-Smith Laboratories, LLCANDACurrent
0832-0274Morphine Sulfatemorphine sulfateUpsher-Smith Laboratories, LLCANDACurrent
0832-0274Morphine Sulfatemorphine sulfateUpsher-Smith Laboratories, LLCANDACurrent
67296-1753Morphine Sulfatemorphine sulfateRedPharm Drug, Inc.ANDACurrent
67296-1753Morphine Sulfatemorphine sulfateRedPharm Drug, Inc.ANDACurrent
67296-1753Morphine Sulfatemorphine sulfateRedPharm Drug, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76447ORIG 2023-11-07
59609ORIG2019-08-07