follitropin beta Injection
- Brand(s)
- Follistim
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Organon Usa Inc. (2014-02-10)
- Oldest Current Product
- 2010-06-28
- License(s)
- NDA
- RxNORM
- INJECTION\FOLLITROPIN BETA
- FDAOB
- SUBCUTANEOUS\INJECTION\FOLLITROPIN ALFA/BETA
- SPL Active
- INTRAMUSCULAR\INJECTION, SOLUTION\FOLLITROPIN
- SPL Moiety
- INTRAMUSCULAR\INJECTION, SOLUTION\FOLLITROPIN
product(s) by strength(s)
0.5 ml follitropin beta 150 unt/ml injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000520308 | Follistim | NDA | Organon Usa Inc. | 2010-06-28 | FOLLITROPIN | INTRAMUSCULAR | INJECTION, SOLUTION | NDA021273 | 56bac591-9f78-4958-8a3b-878d36d3ceca |
0.5 ml follitropin beta 300 unt/ml injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000520309 | Follistim | NDA | Organon Usa Inc. | 2010-06-28 | FOLLITROPIN | INTRAMUSCULAR | INJECTION, SOLUTION | NDA021273 | 56bac591-9f78-4958-8a3b-878d36d3ceca |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug | in other drug docs |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA020378 | GONAL-F | EMD SERONO INC | 1997-09-29 | p7563763, SUBSTANCE p5767067 p5767251 | NDA020378_001, NDA020378_002, NDA020378_003, NDA020378_004, NDA020378_005 | Follitropin Alfa Injectable Solution follitropin beta Cartridge Follitropin Alfa Injection Follitropin Alfa Pen Injector | |
| 2 | NDA021211 | FOLLISTIM AQ | ORGANON USA INC | 2004-02-11 | p7563763, METHOD OF ADMINISTERING FSH FOR THE TREATMENT OF INFERTILITY THROUGH INDUCTION OF OVULATION AND PREGNANCY IN ANOVULATORY INFERTILE WOMEN/ A METHOD FOR ADMINISTERING FOLLICLE STIMULATING HORMONE (FSH) FOR OVARIAN FOLLICLE OR TESTICULAR STIMULATION IN THE HUMAN/ METHOD OF TREATING INFERTILITY p5929028, METHOD OF TREATING INFERTILITY/ TREATMENT OF INFERTILITY THROUGH INDUCTION OF OVULATION AND PREGNANCY TO ANOVULATORY INFERTILE WOMEN, SUBSTANCE p7446090, SUBSTANCE p5767251 | NEW EFFICACY DATA AND DOSING REGIMEN FOR PREGNANCY IN NORMAL OVULATORY WOMEN UNDERGOING CONTROLLED OVARIAN STIMULATION AS PART OF AN IVF OR INTRACYTOPLASMIC SPERM INJECTION (ICSI) CYCLE [2014-08-22] | NDA021211_001, NDA021211_002, NDA021211_003, NDA021211_004 | Follitropin Alfa Injectable Solution follitropin beta Cartridge Follitropin Alfa Injection Follitropin Alfa Pen Injector |
| 3 | NDA021273 | FOLLISTIM AQ | ORGANON USA INC | 2005-08-26 | p5929028, TREATMENT OF INFERTILITY THROUGH INDUCTION OF OVULATION AND PREGNANCY TO ANOVULATORY INFERTILE WOMEN, SUBSTANCE p5767251 | NDA021273_001, NDA021273_002 | Follitropin Alfa Injectable Solution follitropin beta Cartridge Follitropin Alfa Injection Follitropin Alfa Pen Injector | |
| 4 | NDA021684 | GONAL-F RFF REDI-JECT | EMD SERONO INC | 2004-05-25 | p5767067 p7741268, SUBSTANCE p7446090, SUBSTANCE p5767251 | NDA021684_001, NDA021684_002, NDA021684_003 | Follitropin Alfa Injectable Solution follitropin beta Cartridge Follitropin Alfa Injection Follitropin Alfa Pen Injector | |
| 5 | NDA021765 | GONAL-F | EMD SERONO INC | 2004-03-25 | p5767067 p5767251 | NDA021765_001, NDA021765_002, NDA021765_003 | Follitropin Alfa Injectable Solution follitropin beta Cartridge Follitropin Alfa Injection Follitropin Alfa Pen Injector |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA020378_001 | discontinued | FOLLITROPIN ALFA/BETA (75 IU/VIAL) | SUBCUTANEOUS | INJECTION | False | 1997-09-29 | GONAL-F |
| 2 | NDA020378_002 | discontinued | FOLLITROPIN ALFA/BETA (150 IU/VIAL) | SUBCUTANEOUS | INJECTION | False | 1997-09-29 | GONAL-F |
| 3 | NDA020378_003 | discontinued | FOLLITROPIN ALFA/BETA (37.5 IU/VIAL) | SUBCUTANEOUS | INJECTION | False | 2000-05-25 | GONAL-F |
| 4 | NDA020378_004 | RX | FOLLITROPIN ALFA/BETA (1,050 IU/VIAL) | SUBCUTANEOUS | INJECTION | False | 2001-02-28 | GONAL-F |
| 5 | NDA020378_005 | RX | FOLLITROPIN ALFA/BETA (450 IU/VIAL) | SUBCUTANEOUS | INJECTION | True | 2004-03-26 | GONAL-F |
| 6 | NDA021211_001 | RX | FOLLITROPIN ALFA/BETA (300 IU/0.36ML) | SUBCUTANEOUS | INJECTION | True | 2004-03-23 | FOLLISTIM AQ |
| 7 | NDA021211_002 | RX | FOLLITROPIN ALFA/BETA (600 IU/0.72ML) | SUBCUTANEOUS | INJECTION | True | 2004-03-23 | FOLLISTIM AQ |
| 8 | NDA021211_003 | discontinued | FOLLITROPIN ALFA/BETA (150 IU/0.18ML) | SUBCUTANEOUS | INJECTION | False | 2004-02-11 | FOLLISTIM AQ |
| 9 | NDA021211_004 | RX | FOLLITROPIN ALFA/BETA (900 IU/1.08ML) | SUBCUTANEOUS | INJECTION | True | 2005-02-11 | FOLLISTIM AQ |
| 10 | NDA021273_001 | RX | FOLLITROPIN ALFA/BETA (75 IU/0.5ML) | SUBCUTANEOUS | INJECTION | True | 2005-08-26 | FOLLISTIM AQ |
| 11 | NDA021273_002 | RX | FOLLITROPIN ALFA/BETA (150 IU/0.5ML) | SUBCUTANEOUS | INJECTION | True | 2005-08-26 | FOLLISTIM AQ |
| 12 | NDA021684_001 | RX | FOLLITROPIN ALFA/BETA (300 IU/0.5ML) | SUBCUTANEOUS | INJECTION | True | 2004-05-25 | GONAL-F RFF REDI-JECT |
| 13 | NDA021684_002 | RX | FOLLITROPIN ALFA/BETA (450 IU/0.75ML) | SUBCUTANEOUS | INJECTION | True | 2004-05-25 | GONAL-F RFF REDI-JECT |
| 14 | NDA021684_003 | RX | FOLLITROPIN ALFA/BETA (900 IU/1.5ML) | SUBCUTANEOUS | INJECTION | True | 2004-05-25 | GONAL-F RFF REDI-JECT |
| 15 | NDA021765_001 | discontinued | FOLLITROPIN ALFA/BETA (37.5 IU/VIAL) | SUBCUTANEOUS | INJECTION | False | 2004-03-25 | GONAL-F |
| 16 | NDA021765_002 | RX | FOLLITROPIN ALFA/BETA (75 IU/VIAL) | SUBCUTANEOUS | INJECTION | True | 2004-03-25 | GONAL-F |
| 17 | NDA021765_003 | discontinued | FOLLITROPIN ALFA/BETA (150 IU/VIAL) | SUBCUTANEOUS | INJECTION | False | 2004-03-25 | GONAL-F |
patent(s)
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 56bac591-9f78-4958-8a3b-878d36d3ceca (view SPL) | These highlights do not include all the information needed to use Follistim AQ safely and effectively. See full prescribing information for Follistim AQ. Follistim AQ (follitropin beta injection) for subcutaneous or intramuscular use Initial U.S. Approval: 1997 | prescription | Human Prescription | Organon Usa Inc. | API MANUFACTURE, MANUFACTURE, PACK | 2014-02-10 | 9 | 000520308, 000520309 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII