FDA.reportPublic FDA data

Application 017962

Type
NDA
Sponsor
US PHARMS HOLDINGS I

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PARLODELBROMOCRIPTINE MESYLATETABLET;ORALEQ 2.5MG BASEYesNo
002PARLODELBROMOCRIPTINE MESYLATECAPSULE;ORALEQ 5MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
30698-201Parlodelbromocriptine mesylateValidus Pharmaceuticals LLCNDACurrent
30698-201Parlodelbromocriptine mesylateValidus Pharmaceuticals LLCNDACurrent
30698-201Parlodelbromocriptine mesylateValidus Pharmaceuticals LLCNDACurrent
30698-202Parlodelbromocriptine mesylateValidus Pharmaceuticals LLCNDACurrent
30698-202Parlodelbromocriptine mesylateValidus Pharmaceuticals LLCNDACurrent
30698-202Parlodelbromocriptine mesylateValidus Pharmaceuticals LLCNDACurrent
63304-158BROMOCRIPTINE MESYLATEbromocriptine mesylateSun Pharmaceutical Industries, Inc.NDACurrent
63304-158BROMOCRIPTINE MESYLATEbromocriptine mesylateSun Pharmaceutical Industries, Inc.NDACurrent
63304-962BROMOCRIPTINE MESYLATEbromocriptine mesylateSun Pharmaceutical Industries, Inc.NDACurrent
63304-962BROMOCRIPTINE MESYLATEbromocriptine mesylateSun Pharmaceutical Industries, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68071SUPPL2021-07-14
68064SUPPL2021-07-13
61509SUPPL2020-01-03
61306SUPPL2019-12-17
33376SUPPL2012-01-06
13964SUPPL2012-01-06
13963SUPPL2012-01-06
11098SUPPL2012-01-06
40765SUPPL2006-05-08
20097SUPPL2006-05-08
33375SUPPL2005-11-17
13962SUPPL2005-11-17
13961SUPPL2005-11-17
11097SUPPL2005-11-17