FDA.reportPublic FDA data

Application 077042

Type
ANDA
Sponsor
MYLAN

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
0378-6231CitalopramcitalopramMylan Pharmaceuticals Inc.ANDACurrent
0378-6231CitalopramcitalopramMylan Pharmaceuticals Inc.ANDACurrent
0378-6231CitalopramcitalopramMylan Pharmaceuticals Inc.ANDACurrent
0378-6231CitalopramcitalopramMylan Pharmaceuticals Inc.ANDACurrent
0378-6232CitalopramcitalopramMylan Pharmaceuticals Inc.ANDACurrent
0378-6232CitalopramcitalopramMylan Pharmaceuticals Inc.ANDACurrent
0378-6232CitalopramcitalopramMylan Pharmaceuticals Inc.ANDACurrent
0378-6232CitalopramcitalopramMylan Pharmaceuticals Inc.ANDACurrent
0378-6233CitalopramcitalopramMylan Pharmaceuticals Inc.ANDACurrent
0378-6233CitalopramcitalopramMylan Pharmaceuticals Inc.ANDACurrent
0378-6233CitalopramcitalopramMylan Pharmaceuticals Inc.ANDACurrent
0378-6233CitalopramcitalopramMylan Pharmaceuticals Inc.ANDACurrent
53808-0226CitalopramcitalopramState of Florida DOH Central PharmacyANDACurrent
53808-0647CitalopramcitalopramState of Florida DOH Central PharmacyANDACurrent
53808-0906CitalopramcitalopramState of Florida DOH Central PharmacyANDACurrent
63629-6691CitalopramcitalopramBryant Ranch PrepackANDACurrent
63629-6691CitalopramcitalopramBryant Ranch PrepackANDACurrent
67046-101CitalopramcitalopramContract Pharmacy Services-PAANDACurrent
67046-101CitalopramcitalopramContract Pharmacy Services-PAANDACurrent
67046-102CitalopramcitalopramContract Pharmacy Services-PAANDACurrent
67046-102CitalopramcitalopramContract Pharmacy Services-PAANDACurrent
67046-106CitalopramcitalopramContract Pharmacy Services-PAANDACurrent
67046-106CitalopramcitalopramContract Pharmacy Services-PAANDACurrent
67046-111Perrigo CitalopramCitalopramContract Pharmacy Services-PAANDACurrent
70518-0449CitalopramcitalopramREMEDYREPACK INC.ANDACurrent
70518-0449CitalopramcitalopramREMEDYREPACK INC.ANDACurrent
70518-0449CitalopramcitalopramREMEDYREPACK INC.ANDACurrent
70518-0449CitalopramcitalopramREMEDYREPACK INC.ANDACurrent
70518-0449CitalopramcitalopramREMEDYREPACK INC.ANDACurrent
70518-0561CitalopramcitalopramREMEDYREPACK INC.ANDACurrent
70518-0561CitalopramcitalopramREMEDYREPACK INC.ANDACurrent
70518-0561CitalopramcitalopramREMEDYREPACK INC.ANDACurrent
70518-0561CitalopramcitalopramREMEDYREPACK INC.ANDACurrent
70518-0561CitalopramcitalopramREMEDYREPACK INC.ANDACurrent
70518-0561CitalopramcitalopramREMEDYREPACK INC.ANDACurrent
70518-2553CitalopramcitalopramREMEDYREPACK INC.ANDACurrent
70518-2553CitalopramcitalopramREMEDYREPACK INC.ANDACurrent
70518-2553CitalopramcitalopramREMEDYREPACK INC.ANDACurrent
70518-2601CitalopramcitalopramREMEDYREPACK INC.ANDACurrent
70518-2601CitalopramcitalopramREMEDYREPACK INC.ANDACurrent
70518-2601CitalopramcitalopramREMEDYREPACK INC.ANDACurrent
70518-2671CitalopramcitalopramREMEDYREPACK INC.ANDACurrent
70518-2671CitalopramcitalopramREMEDYREPACK INC.ANDACurrent
70518-2671CitalopramcitalopramREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23852ORIG2005-07-29