FDA.reportPublic FDA data

Application 021663

Type
BLA
Sponsor
FERRING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MENOPURMENOTROPINS (FSH;LH)INJECTABLE;SUBCUTANEOUS75 IU/VIAL;75 IU/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55566-7501MenopurmenotropinsFerring Pharmaceuticals Inc.BLACurrent
55566-7501MenopurmenotropinsFerring Pharmaceuticals Inc.BLACurrent
55566-7501MenopurmenotropinsFerring Pharmaceuticals Inc.BLACurrent
55566-7501MenopurmenotropinsFerring Pharmaceuticals Inc.BLACurrent
55566-7501MenopurmenotropinsFerring Pharmaceuticals Inc.BLACurrent
55566-7501MenopurmenotropinsFerring Pharmaceuticals Inc.BLACurrent
55566-7501MenopurmenotropinsFerring Pharmaceuticals Inc.NDACurrent
55566-7501MenopurmenotropinsFerring Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66386APPL2020-03-23
37423SUPPL2020-03-23
28331SUPPL2020-03-23
28330SUPPL2020-03-23
21771ORIG2020-03-23
15941SUPPL2020-03-23
15940SUPPL2020-03-23
15939ORIG2020-03-23
5945SUPPL2020-03-23
5944ORIG2020-03-23