FDA.reportPublic FDA data

Application 077031

Type
ANDA
Sponsor
AUROBINDO

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
0185-0371CitalopramCitalopram HydrobromideEon Labs, Inc.ANDACurrent
0185-0372CitalopramCitalopram HydrobromideEon Labs, Inc.ANDACurrent
0185-0373CitalopramCitalopram HydrobromideEon Labs, Inc.ANDACurrent
0615-8022CitalopramCitalopram HydrobromideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8022CitalopramCitalopram HydrobromideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8023CitalopramCitalopram HydrobromideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8023CitalopramCitalopram HydrobromideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8141CitalopramCitalopram HydrobromideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8141CitalopramCitalopram HydrobromideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-006CitalopramCitalopramBlenheim Pharmacal, Inc.ANDACurrent
13107-005CitalopramCitalopramAurolife Pharma LLCANDACurrent
13107-006CitalopramCitalopramAurolife Pharma LLCANDACurrent
13107-007CitalopramCitalopramAurolife Pharma LLCANDACurrent
42708-019CitalopramCitalopram HydrobromideQPharma IncANDACurrent
42708-019CitalopramCitalopram HydrobromideQPharma IncANDACurrent
42708-019CitalopramCitalopram HydrobromideQPharma IncANDACurrent
43063-670CitalopramCitalopram HydrobromidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-670CitalopramCitalopram HydrobromidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-670CitalopramCitalopram HydrobromidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-670CitalopramCitalopram HydrobromidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-670CitalopramCitalopram HydrobromidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-670CitalopramCitalopram HydrobromidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-670CitalopramCitalopram HydrobromidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-670CitalopramCitalopram HydrobromidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-670CitalopramCitalopram HydrobromidePD-Rx Pharmaceuticals, Inc.ANDACurrent
48433-316CitalopramCitalopram HydrobromideSafecor Health, LLCANDACurrent
50090-3136CitalopramCitalopram HydrobromideA-S Medication SolutionsANDACurrent
50090-3136CitalopramCitalopram HydrobromideA-S Medication SolutionsANDACurrent
50436-0917CitalopramCitalopramUnit Dose ServicesANDACurrent
52959-773CitalopramCitalopramH.J. Harkins Company, Inc.ANDACurrent
53002-1359CitalopramCitalopram HydrobromideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1359CitalopramCitalopram HydrobromideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1360CitalopramCitalopram HydrobromideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1360CitalopramCitalopram HydrobromideRPK Pharmaceuticals, Inc.ANDACurrent
53808-0227CitalopramCitalopram HydrobromideState of Florida DOH Central PharmacyANDACurrent
55700-148CitalopramCitalopram HydrobromideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-148CitalopramCitalopram HydrobromideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-148CitalopramCitalopram HydrobromideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-324CitalopramCitalopram HydrobromideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-324CitalopramCitalopram HydrobromideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-356CitalopramCitalopram HydrobromideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-356CitalopramCitalopram HydrobromideLake Erie Medical DBA Quality Care Products LLCANDACurrent
63187-140CitalopramCitalopram HydrobromideProficient Rx LPANDACurrent
63187-140CitalopramCitalopram HydrobromideProficient Rx LPANDACurrent
63187-140CitalopramCitalopram HydrobromideProficient Rx LPANDACurrent
63187-140CitalopramCitalopram HydrobromideProficient Rx LPANDACurrent
63187-679CitalopramCitalopram HydrobromideProficient Rx LPANDACurrent
63187-679CitalopramCitalopram HydrobromideProficient Rx LPANDACurrent
65862-005CitalopramCitalopram HydrobromideAurobindo Pharma LimitedANDACurrent
65862-005CitalopramCitalopram HydrobromideAurobindo Pharma LimitedANDACurrent
65862-005CitalopramCitalopram HydrobromideAurobindo Pharma LimitedANDACurrent
65862-005CitalopramCitalopram HydrobromideAurobindo Pharma LimitedANDACurrent
65862-005CitalopramCitalopram HydrobromideAurobindo Pharma LimitedANDACurrent
65862-006CitalopramCitalopram HydrobromideAurobindo Pharma LimitedANDACurrent
65862-006CitalopramCitalopram HydrobromideAurobindo Pharma LimitedANDACurrent
65862-006CitalopramCitalopram HydrobromideAurobindo Pharma LimitedANDACurrent
65862-006CitalopramCitalopram HydrobromideAurobindo Pharma LimitedANDACurrent
65862-006CitalopramCitalopram HydrobromideAurobindo Pharma LimitedANDACurrent
65862-007CitalopramCitalopram HydrobromideAurobindo Pharma LimitedANDACurrent
65862-007CitalopramCitalopram HydrobromideAurobindo Pharma LimitedANDACurrent
65862-007CitalopramCitalopram HydrobromideAurobindo Pharma LimitedANDACurrent
65862-007CitalopramCitalopram HydrobromideAurobindo Pharma LimitedANDACurrent
65862-007CitalopramCitalopram HydrobromideAurobindo Pharma LimitedANDACurrent
67046-112CitalopramCitalopram HydrobromideContract Pharmacy Services-PAANDACurrent
67046-115CitalopramCitalopram HydrobromideContract Pharmacy Services-PAANDACurrent
67296-0683CitalopramCitalopram HydrobromideRedPharm Drug Inc.ANDACurrent
68071-3042CitalopramCitalopram HydrobromideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3357CitalopramCitalopram HydrobromideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4604CitalopramCitalopram HydrobromideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4604CitalopramCitalopram HydrobromideNuCare Pharmaceuticals,Inc.ANDACurrent
68084-737CitalopramCitalopram HydrobromideAmerican Health PackagingANDACurrent
68084-737CitalopramCitalopram HydrobromideAmerican Health PackagingANDACurrent
68084-737CitalopramCitalopram HydrobromideAmerican Health PackagingANDACurrent
68084-737CitalopramCitalopram HydrobromideAmerican Health PackagingANDACurrent
68084-737CitalopramCitalopram HydrobromideAmerican Health PackagingANDACurrent
68084-744CitalopramCitalopram HydrobromideAmerican Health PackagingANDACurrent
68084-744CitalopramCitalopram HydrobromideAmerican Health PackagingANDACurrent
68084-744CitalopramCitalopram HydrobromideAmerican Health PackagingANDACurrent
68084-744CitalopramCitalopram HydrobromideAmerican Health PackagingANDACurrent
68084-744CitalopramCitalopram HydrobromideAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23846ORIG2005-07-29
8994ORIG2004-10-29