FDA.report

Application 078406

Type
ANDA
Sponsor
AUROBINDO PHARMA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDETABLET;ORALEQ 10MG BASENoNo
002PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDETABLET;ORALEQ 20MG BASENoNo
003PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDETABLET;ORALEQ 30MG BASENoNo
004PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDETABLET;ORALEQ 40MG BASENoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8359ParoxetineParoxetineNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8359ParoxetineParoxetineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
13107-154ParoxetineParoxetineAurolife Pharma, LLCANDACurrent
13107-154ParoxetineParoxetineAurolife Pharma, LLCANDACurrent
13107-154ParoxetineParoxetineAurolife Pharma LLCANDACurrent
13107-154ParoxetineParoxetineAurolife Pharma LLCANDACurrent
13107-154ParoxetineParoxetineAurolife Pharma LLCANDACurrent
13107-155ParoxetineParoxetineAurolife Pharma LLCANDACurrent
13107-155ParoxetineParoxetineAurolife Pharma, LLCANDACurrent
13107-155ParoxetineParoxetineAurolife Pharma, LLCANDACurrent
13107-155ParoxetineParoxetineAurolife Pharma LLCANDACurrent
13107-155ParoxetineParoxetineAurolife Pharma LLCANDACurrent
13107-156ParoxetineParoxetineAurolife Pharma LLCANDACurrent
13107-156ParoxetineParoxetineAurolife Pharma LLCANDACurrent
13107-156ParoxetineParoxetineAurolife Pharma LLCANDACurrent
13107-156ParoxetineParoxetineAurolife Pharma, LLCANDACurrent
13107-156ParoxetineParoxetineAurolife Pharma, LLCANDACurrent
13107-157ParoxetineParoxetineAurolife Pharma LLCANDACurrent
13107-157ParoxetineParoxetineAurolife Pharma, LLCANDACurrent
13107-157ParoxetineParoxetineAurolife Pharma, LLCANDACurrent
13107-157ParoxetineParoxetineAurolife Pharma LLCANDACurrent
13107-157ParoxetineParoxetineAurolife Pharma LLCANDACurrent
16714-181ParoxetineParoxetine HydrochlorideNorthStar Rx LLCANDACurrent
16714-182ParoxetineParoxetine HydrochlorideNorthStar Rx LLCANDACurrent
16714-183ParoxetineParoxetine HydrochlorideNorthStar Rx LLCANDACurrent
16714-184ParoxetineParoxetine HydrochlorideNorthStar Rx LLCANDACurrent
35356-892ParoxetineParoxetineLake Erie Medical DBA Quality Care Products LLCANDACurrent
43353-713ParoxetineParoxetineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-845ParoxetineParoxetine HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-994ParoxetineParoxetine HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-0848ParoxetineParoxetineA-S Medication SolutionsANDACurrent
50090-0848ParoxetineParoxetineA-S Medication SolutionsANDACurrent
50090-0921ParoxetineParoxetineA-S Medication SolutionsANDACurrent
50090-2143ParoxetineParoxetineA-S Medication SolutionsANDACurrent
50090-2143ParoxetineParoxetineA-S Medication SolutionsANDACurrent
50268-640ParoxetineParoxetineAvPAKANDACurrent
50268-640ParoxetineParoxetineAvPAKANDACurrent
50268-640ParoxetineParoxetineAvPAKANDACurrent
50268-640ParoxetineParoxetineAvPAKANDACurrent
50268-640ParoxetineParoxetineAvPAKANDACurrent
50268-640ParoxetineParoxetineAvPAKANDACurrent
50268-641ParoxetineParoxetineAvPAKANDACurrent
50268-642ParoxetineParoxetineAvPAKANDACurrent
50268-642ParoxetineParoxetineAvPAKANDACurrent
50268-642ParoxetineParoxetineAvPAKANDACurrent
50268-642ParoxetineParoxetineAvPAKANDACurrent
50268-642ParoxetineParoxetineAvPAKANDACurrent
50268-642ParoxetineParoxetineAvPAKANDACurrent
50268-643ParoxetineParoxetineAvPAKANDACurrent
50268-643ParoxetineParoxetineAvPAKANDACurrent
50268-643ParoxetineParoxetineAvPAKANDACurrent
50268-643ParoxetineParoxetineAvPAKANDACurrent
50268-643ParoxetineParoxetineAvPAKANDACurrent
50268-643ParoxetineParoxetineAvPAKANDACurrent
52343-073ParoxetineParoxetine HydrochlorideACETRIS HEALTH, LLCANDACurrent
52343-073ParoxetineParoxetine HydrochlorideLUCID PHARMA LLCANDACurrent
52343-074ParoxetineParoxetine HydrochlorideLUCID PHARMA LLCANDACurrent
52343-074ParoxetineParoxetine HydrochlorideACETRIS HEALTH, LLCANDACurrent
52343-075ParoxetineParoxetine HydrochlorideACETRIS HEALTH, LLCANDACurrent
52343-075ParoxetineParoxetine HydrochlorideLUCID PHARMA LLCANDACurrent
52343-076ParoxetineParoxetine HydrochlorideACETRIS HEALTH, LLCANDACurrent
52343-076ParoxetineParoxetine HydrochlorideLUCID PHARMA LLCANDACurrent
53808-0749ParoxetinePAROXETINE HYDROCHLORIDEState of Florida DOH Central PharmacyANDACurrent
53808-0752ParoxetinePAROXETINE HYDROCHLORIDEState of Florida DOH Central PharmacyANDACurrent
53808-0756ParoxetinePAROXETINE HYDROCHLORIDEState of Florida DOH Central PharmacyANDACurrent
55700-040ParoxetineParoxetineLake Erie Medical DBA Quality Care Products LLCANDACurrent
63187-564ParoxetineParoxetineProficient Rx LPANDACurrent
63187-564ParoxetineParoxetineProficient Rx LPANDACurrent
65862-154ParoxetineParoxetine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-154ParoxetineParoxetine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-154ParoxetineParoxetine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-154ParoxetineParoxetine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-155ParoxetineParoxetine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-155ParoxetineParoxetine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-155ParoxetineParoxetine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-155ParoxetineParoxetine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-156ParoxetineParoxetine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-156ParoxetineParoxetine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-156ParoxetineParoxetine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-156ParoxetineParoxetine HydrochlorideAurobindo Pharma LimitedANDACurrent

Documents

DocumentSubmission typeDate
23905ORIG2007-08-16