Follicle Stimulating Hormone / Luteinizing Hormone Injectable Solution

Brand(s)
Menopur
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Ferring Pharmaceuticals Inc. (2015-11-16)
Oldest Current Product
2004-10-29
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\FOLLICLE STIMULATING HORMONE:LUTEINIZING HORMONE
FDAOB
SUBCUTANEOUS\INJECTION\LH): MENOTROPINS (FSH

product(s) by strength(s)

follicle stimulating hormone 75 unt/ml / luteinizing hormone 75 unt/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1555667501MenopurNDAFerring Pharmaceuticals Inc.2004-10-29NDA02166322c8db95-c3db-1770-8086-31356fbabe35

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1NDA021663MENOPURFERRING PHARMACEUTICALS INC2004-10-29ADDITIONAL INFORMATION ADDED TO THE DOSING AND ADMINISTRATION SECTION OF THE LABELING REGARDING THE ADMINISTRATION OF BRAVELLE AND MENOPUR IN THE SAME SYRINGE TO OVULATORY WOMEN AS PART OF AN ART CYCLE [2017-02-19]NDA021663_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021663_001RXMENOTROPINS (FSH (75 IU/VIAL), LH) (75 IU/VIAL)SUBCUTANEOUSINJECTIONTrue2004-10-29MENOPUR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
122c8db95-c3db-1770-8086-31356fbabe35 (view SPL)These highlights do not include all the information needed to use MENOPUR safely and effectively. See full prescribing information for MENOPUR. MENOPUR (menotropins for injection) for subcutaneous use. Initial U.S. Approval: 1975prescriptionHuman PrescriptionFerring Pharmaceuticals Inc.API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-11-1613555667501

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII