FDA.reportPublic FDA data

Application 011790

Type
NDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROBAXINMETHOCARBAMOLSOLUTION;IM-IV1GM/10ML (100MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0641-6103ROBAXINmethocarbamolWest-Ward Pharmaceuticals Corp.NDACurrent
0641-6217ROBAXINmethocarbamolWest-Ward Pharmaceuticals Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
11959SUPPL2004-05-04
10779SUPPL2004-05-04