FDA.reportPublic FDA data

Application 040866

Type
ANDA
Sponsor
AMNEAL PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRIMIDONEPRIMIDONETABLET;ORAL50MGNoNo
002PRIMIDONEPRIMIDONETABLET;ORAL250MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8206PrimidonePrimidoneNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
42291-509PrimidonePrimidoneAvKAREANDACurrent
42291-511PrimidonePrimidoneAvKARE, Inc.ANDACurrent
42291-511PrimidonePrimidoneAvKAREANDACurrent
50090-1636PrimidonePrimidoneA-S Medication SolutionsANDACurrent
50090-1636PrimidonePrimidoneA-S Medication SolutionsANDACurrent
50090-4083PrimidonePrimidoneA-S Medication SolutionsANDACurrent
50090-4083PrimidonePrimidoneA-S Medication SolutionsANDACurrent
50268-686PrimidonePrimidoneAvPAKANDACurrent
50268-686PrimidonePrimidoneAvPAKANDACurrent
50268-687PrimidonePrimidoneAvPAKANDACurrent
50268-687PrimidonePrimidoneAvPAKANDACurrent
53746-544PrimidonePrimidoneAmneal Pharmaceuticals of New York LLCANDACurrent
53746-544PrimidonePrimidoneAmneal Pharmaceuticals of New York LLCANDACurrent
53746-544PrimidonePrimidoneAmneal Pharmaceuticals of New York LLCANDACurrent
53746-544PrimidonePrimidoneAmneal Pharmaceuticals of New York LLCANDACurrent
53746-544PrimidonePrimidoneAmneal Pharmaceuticals of New York LLCANDACurrent
53746-544PrimidonePrimidoneAmneal Pharmaceuticals of New York LLCANDACurrent
53746-544PrimidonePrimidoneAmneal Pharmaceuticals of New York LLCANDACurrent
53746-545PrimidonePrimidoneAmneal Pharmaceuticals of New York LLCANDACurrent
53746-545PrimidonePrimidoneAmneal Pharmaceuticals of New York LLCANDACurrent
53746-545PrimidonePrimidoneAmneal Pharmaceuticals of New York LLCANDACurrent
53746-545PrimidonePrimidoneAmneal Pharmaceuticals of New York LLCANDACurrent
53746-545PrimidonePrimidoneAmneal Pharmaceuticals of New York LLCANDACurrent
53746-545PrimidonePrimidoneAmneal Pharmaceuticals of New York LLCANDACurrent
53746-545PrimidonePrimidoneAmneal Pharmaceuticals of New York LLCANDACurrent
63629-7811PrimidonePrimidoneBryant Ranch PrepackANDACurrent
63629-7811PrimidonePrimidoneBryant Ranch PrepackANDACurrent
63629-7811PrimidonePrimidoneBryant Ranch PrepackANDACurrent
65162-544PrimidonePrimidoneAmneal Pharmaceuticals LLCANDACurrent
65162-544PrimidonePrimidoneAmneal Pharmaceuticals LLCANDACurrent
65162-544PrimidonePrimidoneAmneal Pharmaceuticals LLCANDACurrent
65162-544PrimidonePrimidoneAmneal Pharmaceuticals LLCANDACurrent
65162-544PrimidonePrimidoneAmneal Pharmaceuticals LLCANDACurrent
65162-545PrimidonePrimidoneAmneal Pharmaceuticals LLCANDACurrent
65162-545PrimidonePrimidoneAmneal Pharmaceuticals LLCANDACurrent
65162-545PrimidonePrimidoneAmneal Pharmaceuticals LLCANDACurrent
65162-545PrimidonePrimidoneAmneal Pharmaceuticals LLCANDACurrent
65162-545PrimidonePrimidoneAmneal Pharmaceuticals LLCANDACurrent