FDA.reportPublic FDA data

Application 020682

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYSETMIGLITOLTABLET;ORAL25MGYesYes
002GLYSETMIGLITOLTABLET;ORAL50MGYesNo
003GLYSETMIGLITOLTABLET;ORAL100MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-5012GlysetmiglitolPharmacia and Upjohn Company LLCNDACurrent
0009-5012GlysetmiglitolPharmacia & Upjohn Company LLCNDACurrent
0009-5012GlysetmiglitolPharmacia and Upjohn Company LLCNDACurrent
0009-5013GlysetmiglitolPharmacia and Upjohn Company LLCNDACurrent
0009-5013GlysetmiglitolPharmacia & Upjohn Company LLCNDACurrent
0009-5013GlysetmiglitolPharmacia and Upjohn Company LLCNDACurrent
0009-5014GlysetmiglitolPharmacia and Upjohn Company LLCNDACurrent
0009-5014GlysetmiglitolPharmacia & Upjohn Company LLCNDACurrent
0009-5014GlysetmiglitolPharmacia and Upjohn Company LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57686ORIG2019-02-15
25499SUPPL2012-09-20
13188SUPPL2012-09-17
35127SUPPL2009-05-13
25498SUPPL2009-05-04
41544SUPPL1999-08-16
3064SUPPL1999-08-16