Application 021289

Type
BLA
Sponsor
FERRING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BRAVELLEUROFOLLITROPININJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS75 IU/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55566-8505BravelleUrofollitropinFerring Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66729ORIG2021-03-10
42084ORIG2020-03-23
36594ORIG2020-03-23
14903SUPPL2020-03-23
4936SUPPL2020-03-23
4935ORIG2020-03-23
66431APPL2020-03-22