FDA.reportPublic FDA data

Application 212595

Type
NDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIOMET ERMETFORMIN HYDROCHLORIDEFOR SUSPENSION, EXTENDED RELEASE;ORAL500MG/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10631-019RIOMET ERMetformin HydrochlorideSun Pharmaceutical Industries Inc.NDACurrent
10631-019RIOMET ERMetformin HydrochlorideSun Pharmaceutical Industries Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61864ORIG2020-02-11
59886ORIG2019-08-30
59880ORIG2019-08-30
63143ORIG1900-01-01
63142ORIG1900-01-01