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)
| # | id | brand | category | labeler | first marketed | application | spl |
|---|---|---|---|---|---|---|---|
| 1 | 555667501 | Menopur | NDA | Ferring Pharmaceuticals Inc. | 2004-10-29 | NDA021663 | 22c8db95-c3db-1770-8086-31356fbabe35 |
application(s)
| # | id | title | applicant | approved | exclusivity | approved drug |
|---|---|---|---|---|---|---|
| 1 | NDA021663 | MENOPUR | FERRING PHARMACEUTICALS INC | 2004-10-29 | ADDITIONAL 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)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA021663_001 | RX | MENOTROPINS (FSH (75 IU/VIAL), LH) (75 IU/VIAL) | SUBCUTANEOUS | INJECTION | True | 2004-10-29 | MENOPUR |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 22c8db95-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: 1975 | prescription | Human Prescription | Ferring Pharmaceuticals Inc. | API MANUFACTURE, LABEL, MANUFACTURE, PACK | 2015-11-16 | 13 | 555667501 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII