Application 019815

Type
NDA
Sponsor
SHIRE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROAMATINEMIDODRINE HYDROCHLORIDETABLET;ORAL2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002PROAMATINEMIDODRINE HYDROCHLORIDETABLET;ORAL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003PROAMATINEMIDODRINE HYDROCHLORIDETABLET;ORAL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47236SUPPL2017-02-16
47135SUPPL2017-02-08
19255SUPPL2004-07-28
41043SUPPL2002-03-20
1643SUPPL2002-03-20
57443ORIG1996-09-06