FDA.report

Application 040197

Type
ANDA
Sponsor
BARR LABS INC

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ESTRADIOLESTRADIOLTABLET;ORAL0.5MGNoNo
002ESTRADIOLESTRADIOLTABLET;ORAL1MGNoNo
003ESTRADIOLESTRADIOLTABLET;ORAL2MGNoYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-1999EstradiolEstradiolKAISER FOUNDATION HOSPITALSANDACurrent
0430-0720EstraceEstradiolAllergan, Inc.ANDACurrent
0430-0720EstraceEstradiolAllergan, Inc.ANDACurrent
0430-0720EstraceEstradiolAllergan, Inc.ANDACurrent
0430-0720EstraceEstradiolAllergan, Inc.ANDACurrent
0430-0721EstraceEstradiolAllergan, Inc.ANDACurrent
0430-0721EstraceEstradiolAllergan, Inc.ANDACurrent
0430-0721EstraceEstradiolAllergan, Inc.ANDACurrent
0430-0721EstraceEstradiolAllergan, Inc.ANDACurrent
0430-0722EstraceEstradiolAllergan, Inc.ANDACurrent
0430-0722EstraceEstradiolAllergan, Inc.ANDACurrent
0430-0722EstraceEstradiolAllergan, Inc.ANDACurrent
0430-0722EstraceEstradiolAllergan, Inc.ANDACurrent
0555-0886EstradiolEstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0886EstradiolEstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0886EstradiolEstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0886EstradiolEstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0886EstradiolEstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0887EstradiolEstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0887EstradiolEstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0887EstradiolEstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0887EstradiolEstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0887EstradiolEstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0899EstradiolEstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0899EstradiolEstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0899EstradiolEstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0899EstradiolEstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0899EstradiolEstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
33261-667EstradiolEstradiolAidarex Pharmaceuticals LLCANDACurrent
33261-714EstradiolEstradiolAidarex Pharmaceuticals LLCANDACurrent
43063-706EstradiolEstradiolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-706EstradiolEstradiolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-706EstradiolEstradiolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-706EstradiolEstradiolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-706EstradiolEstradiolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-717EstradiolEstradiolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-717EstradiolEstradiolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-717EstradiolEstradiolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-717EstradiolEstradiolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-717EstradiolEstradiolPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-1704EstradiolEstradiolA-S Medication SolutionsANDACurrent
50090-1704EstradiolEstradiolA-S Medication SolutionsANDACurrent
50090-1704EstradiolEstradiolA-S Medication SolutionsANDACurrent
50090-1876EstradiolEstradiolA-S Medication SolutionsANDACurrent
50090-1876EstradiolEstradiolA-S Medication SolutionsANDACurrent
50090-1882EstradiolEstradiolA-S Medication SolutionsANDACurrent
50090-1882EstradiolEstradiolA-S Medication SolutionsANDACurrent
51862-332EstradiolEstradiolMayne Pharma Inc.ANDACurrent
51862-332EstradiolEstradiolMayne Pharma Inc.ANDACurrent
51862-332EstradiolEstradiolMayne Pharma Inc.ANDACurrent
51862-333EstradiolEstradiolMayne Pharma Inc.ANDACurrent
51862-333EstradiolEstradiolMayne Pharma Inc.ANDACurrent
51862-333EstradiolEstradiolMayne Pharma Inc.ANDACurrent
51862-334EstradiolEstradiolMayne Pharma Inc.ANDACurrent
51862-334EstradiolEstradiolMayne Pharma Inc.ANDACurrent
51862-334EstradiolEstradiolMayne Pharma Inc.ANDACurrent
54348-701EstradiolESTRADIOLPharmPak, Inc.ANDACurrent
54348-701EstradiolESTRADIOLPharmPak, Inc.ANDACurrent
54348-702EstradiolESTRADIOLPharmPak, Inc.ANDACurrent
54348-702EstradiolESTRADIOLPharmPak, Inc.ANDACurrent
55700-458EstradiolEstradiolLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-504EstradiolEstradiolLake Erie Medical DBA Quality Care Products LLCANDACurrent
60429-833EstradiolEstradiolGolden State Medical Supply, Inc.ANDACurrent
60429-833EstradiolEstradiolGolden State Medical Supply, Inc.ANDACurrent
60429-833EstradiolEstradiolGolden State Medical Supply, Inc.ANDACurrent
60429-833EstradiolEstradiolGolden State Medical Supply, Inc.ANDACurrent
60429-834EstradiolEstradiolGolden State Medical Supply, Inc.ANDACurrent
60429-834EstradiolEstradiolGolden State Medical Supply, Inc.ANDACurrent
60429-834EstradiolEstradiolGolden State Medical Supply, Inc.ANDACurrent
60429-834EstradiolEstradiolGolden State Medical Supply, Inc.ANDACurrent
60429-835EstradiolEstradiolGolden State Medical Supply, Inc.ANDACurrent
60429-835EstradiolEstradiolGolden State Medical Supply, Inc.ANDACurrent
60429-835EstradiolEstradiolGolden State Medical Supply, Inc.ANDACurrent
61919-194ESTRADIOLESTRADIOLDirectRXANDACurrent
61919-195ESTRADIOLESTRADIOLDirect_RxANDACurrent
61919-198ESTRADIOLESTRADIOLDirectRXANDACurrent
61919-198ESTRADIOLESTRADIOLDirect_RxANDACurrent
61919-198ESTRADIOLESTRADIOLDirect_RxANDACurrent
61919-278ESTRADIOLESTRADIOLDirect_RxANDACurrent
63187-741EstradiolEstradiolProficient Rx LPANDACurrent

Documents

DocumentTitleSubmission typeSubmission no.Date
425930ORIG12011-03-10