FDA.reportPublic FDA data

Application 077289

Type
ANDA
Sponsor
AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDETABLET;ORALEQ 10MG BASENoNo
002CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDETABLET;ORALEQ 20MG BASENoNo
003CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDETABLET;ORALEQ 40MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43063-063CitalopramCitalopramPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-063CitalopramCitalopramPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-063CitalopramCitalopramPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-063CitalopramCitalopramPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-063CitalopramCitalopramPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-063CitalopramCitalopramPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-385CitalopramCitalopramPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-385CitalopramCitalopramPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-385CitalopramCitalopramPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-385CitalopramCitalopramPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-385CitalopramCitalopramPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-385CitalopramCitalopramPD-Rx Pharmaceuticals, Inc.ANDACurrent
49999-654CitalopramCitalopramLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-2732CitalopramCitalopramA-S Medication SolutionsANDACurrent
53401-200CitalopramCitalopramAphena Pharma Solutions - New Jersey, LLCANDACurrent
53401-201CitalopramCitalopramAphena Pharma Solutions - New Jersey, LLCANDACurrent
53401-202CitalopramCitalopramAphena Pharma Solutions - New Jersey, LLCANDACurrent
53808-1077CitalopramCitalopramState of Florida DOH Central PharmacyANDACurrent
61919-288CITALOPRAMCITALOPRAMDIRECT RXANDACurrent
65162-052CitalopramCitalopramAmneal Pharmaceuticals LLCANDACurrent
65162-052CitalopramCitalopramAmneal Pharmaceuticals LLCANDACurrent
65162-052CitalopramCitalopramAmneal Pharmaceuticals LLCANDACurrent
65162-052CitalopramCitalopramAmneal Pharmaceuticals LLCANDACurrent
65162-052CitalopramCitalopramAmneal Pharmaceuticals LLCANDACurrent
65162-052CitalopramCitalopramAmneal Pharmaceuticals LLCANDACurrent
65162-052CitalopramCitalopramAmneal Pharmaceuticals LLCANDACurrent
65162-053CitalopramCitalopramAmneal Pharmaceuticals LLCANDACurrent
65162-053CitalopramCitalopramAmneal Pharmaceuticals LLCANDACurrent
65162-053CitalopramCitalopramAmneal Pharmaceuticals LLCANDACurrent
65162-053CitalopramCitalopramAmneal Pharmaceuticals LLCANDACurrent
65162-053CitalopramCitalopramAmneal Pharmaceuticals LLCANDACurrent
65162-053CitalopramCitalopramAmneal Pharmaceuticals LLCANDACurrent
65162-053CitalopramCitalopramAmneal Pharmaceuticals LLCANDACurrent
65162-054CitalopramCitalopramAmneal Pharmaceuticals LLCANDACurrent
65162-054CitalopramCitalopramAmneal Pharmaceuticals LLCANDACurrent
65162-054CitalopramCitalopramAmneal Pharmaceuticals LLCANDACurrent
65162-054CitalopramCitalopramAmneal Pharmaceuticals LLCANDACurrent
65162-054CitalopramCitalopramAmneal Pharmaceuticals LLCANDACurrent
65162-054CitalopramCitalopramAmneal Pharmaceuticals LLCANDACurrent
65162-054CitalopramCitalopramAmneal Pharmaceuticals LLCANDACurrent
67046-107CitalopramCitalopramContract Pharmacy Services-PAANDACurrent
67046-108CitalopramCitalopramContract Pharmacy Services-PAANDACurrent
67046-109CitalopramCitalopramContract Pharmacy Services-PAANDACurrent
68071-3034CitalopramCitalopramNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3034CitalopramCitalopramNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3034CitalopramCitalopramNuCare Pharmaceuticals, Inc.ANDACurrent
68788-6810CitalopramCitalopramPreferred Pharmaceuticals Inc.ANDACurrent