FDA.reportPublic FDA data

Application 020664

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOSTINEXCABERGOLINETABLET;ORAL0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59762-1005CabergolinecabergolineGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1005CabergolinecabergolineGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1005CabergolinecabergolineGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81996SUPPL 2025-04-25
81991SUPPL 2025-04-25
61309SUPPL2019-12-17
61284SUPPL2019-12-16
3030SUPPL2014-09-10
35105SUPPL2014-08-27
25469SUPPL2011-10-20
12948SUPPL2011-08-12
25468SUPPL2011-07-21
12947SUPPL2011-07-18
20808ORIG2010-01-05
25467SUPPL2008-01-09
35104SUPPL2007-12-27
3029SUPPL2007-02-23
12946SUPPL2007-02-21
25466SUPPL2006-12-28
35103SUPPL2006-12-14