follitropin beta Cartridge

Brand(s)
Follistim
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Organon Usa Inc. (2014-12-22)
Oldest Current Product
2004-03-24
License(s)
NDA
RxNORM
CARTRIDGE\FOLLITROPIN BETA
FDAOB
SUBCUTANEOUS\INJECTION\FOLLITROPIN ALFA/BETA
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\FOLLITROPIN
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\FOLLITROPIN

product(s) by strength(s)

1.08 ml follitropin beta 833 unt/ml cartridge

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000520326FollistimNDAOrganon Usa Inc.2004-03-24FOLLITROPINSUBCUTANEOUSINJECTION, SOLUTIONNDA02121196f11b5d-cc7b-48aa-830a-a28e1962d871

0.36 ml follitropin beta 833 unt/ml cartridge

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000520313FollistimNDAOrganon Usa Inc.2004-03-24FOLLITROPINSUBCUTANEOUSINJECTION, SOLUTIONNDA02121196f11b5d-cc7b-48aa-830a-a28e1962d871

0.72 ml follitropin beta 833 unt/ml cartridge

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000520316FollistimNDAOrganon Usa Inc.2004-03-24FOLLITROPINSUBCUTANEOUSINJECTION, SOLUTIONNDA02121196f11b5d-cc7b-48aa-830a-a28e1962d871

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drugin other drug docs
1NDA020378GONAL-FEMD SERONO INC1997-09-29p7563763, SUBSTANCE
p5767067
p5767251
NDA020378_001, NDA020378_002, NDA020378_003, NDA020378_004, NDA020378_005Follitropin Alfa Injectable Solution
follitropin beta Injection
Follitropin Alfa Injection
Follitropin Alfa Pen Injector
2NDA021211FOLLISTIM AQORGANON USA INC2004-02-11p7563763, 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_004Follitropin Alfa Injectable Solution
follitropin beta Injection
Follitropin Alfa Injection
Follitropin Alfa Pen Injector
3NDA021273FOLLISTIM AQORGANON USA INC2005-08-26p5929028, TREATMENT OF INFERTILITY THROUGH INDUCTION OF OVULATION AND PREGNANCY TO ANOVULATORY INFERTILE WOMEN, SUBSTANCE
p5767251
NDA021273_001, NDA021273_002Follitropin Alfa Injectable Solution
follitropin beta Injection
Follitropin Alfa Injection
Follitropin Alfa Pen Injector
4NDA021684GONAL-F RFF REDI-JECTEMD SERONO INC2004-05-25p5767067
p7741268, SUBSTANCE
p7446090, SUBSTANCE
p5767251
NDA021684_001, NDA021684_002, NDA021684_003Follitropin Alfa Injectable Solution
follitropin beta Injection
Follitropin Alfa Injection
Follitropin Alfa Pen Injector
5NDA021765GONAL-FEMD SERONO INC2004-03-25p5767067
p5767251
NDA021765_001, NDA021765_002, NDA021765_003Follitropin Alfa Injectable Solution
follitropin beta Injection
Follitropin Alfa Injection
Follitropin Alfa Pen Injector

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020378_001discontinuedFOLLITROPIN ALFA/BETA (75 IU/VIAL)SUBCUTANEOUSINJECTIONFalse1997-09-29GONAL-F
2NDA020378_002discontinuedFOLLITROPIN ALFA/BETA (150 IU/VIAL)SUBCUTANEOUSINJECTIONFalse1997-09-29GONAL-F
3NDA020378_003discontinuedFOLLITROPIN ALFA/BETA (37.5 IU/VIAL)SUBCUTANEOUSINJECTIONFalse2000-05-25GONAL-F
4NDA020378_004RXFOLLITROPIN ALFA/BETA (1,050 IU/VIAL)SUBCUTANEOUSINJECTIONFalse2001-02-28GONAL-F
5NDA020378_005RXFOLLITROPIN ALFA/BETA (450 IU/VIAL)SUBCUTANEOUSINJECTIONTrue2004-03-26GONAL-F
6NDA021211_001RXFOLLITROPIN ALFA/BETA (300 IU/0.36ML)SUBCUTANEOUSINJECTIONTrue2004-03-23FOLLISTIM AQ
7NDA021211_002RXFOLLITROPIN ALFA/BETA (600 IU/0.72ML)SUBCUTANEOUSINJECTIONTrue2004-03-23FOLLISTIM AQ
8NDA021211_003discontinuedFOLLITROPIN ALFA/BETA (150 IU/0.18ML)SUBCUTANEOUSINJECTIONFalse2004-02-11FOLLISTIM AQ
9NDA021211_004RXFOLLITROPIN ALFA/BETA (900 IU/1.08ML)SUBCUTANEOUSINJECTIONTrue2005-02-11FOLLISTIM AQ
10NDA021273_001RXFOLLITROPIN ALFA/BETA (75 IU/0.5ML)SUBCUTANEOUSINJECTIONTrue2005-08-26FOLLISTIM AQ
11NDA021273_002RXFOLLITROPIN ALFA/BETA (150 IU/0.5ML)SUBCUTANEOUSINJECTIONTrue2005-08-26FOLLISTIM AQ
12NDA021684_001RXFOLLITROPIN ALFA/BETA (300 IU/0.5ML)SUBCUTANEOUSINJECTIONTrue2004-05-25GONAL-F RFF REDI-JECT
13NDA021684_002RXFOLLITROPIN ALFA/BETA (450 IU/0.75ML)SUBCUTANEOUSINJECTIONTrue2004-05-25GONAL-F RFF REDI-JECT
14NDA021684_003RXFOLLITROPIN ALFA/BETA (900 IU/1.5ML)SUBCUTANEOUSINJECTIONTrue2004-05-25GONAL-F RFF REDI-JECT
15NDA021765_001discontinuedFOLLITROPIN ALFA/BETA (37.5 IU/VIAL)SUBCUTANEOUSINJECTIONFalse2004-03-25GONAL-F
16NDA021765_002RXFOLLITROPIN ALFA/BETA (75 IU/VIAL)SUBCUTANEOUSINJECTIONTrue2004-03-25GONAL-F
17NDA021765_003discontinuedFOLLITROPIN ALFA/BETA (150 IU/VIAL)SUBCUTANEOUSINJECTIONFalse2004-03-25GONAL-F

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5767067 (view patent)2015-06-16NDA020378, NDA021684, NDA021765, NDA019415Follitropin Alfa Injectable Solution
follitropin beta Injection
Follitropin Alfa Injection
Follitropin Alfa Pen Injector
2p5767251 (view patent)2015-06-16NDA020378, NDA021211, NDA021273, NDA021684, NDA021765, NDA020582, NDA021149, NDA021322Chorionic Gonadotropin Prefilled Syringe
Follitropin Alfa Injectable Solution
follitropin beta Injection
Follitropin Alfa Injection
Follitropin Alfa Pen Injector
3p5929028 (view patent)2018-01-14NDA021211, NDA021273Follitropin Alfa Injectable Solution
follitropin beta Injection
Follitropin Alfa Injection
Follitropin Alfa Pen Injector
4p7446090 (view patent)2019-08-23NDA021211, NDA021684Follitropin Alfa Injectable Solution
follitropin beta Injection
Follitropin Alfa Injection
Follitropin Alfa Pen Injector
5p7563763 (view patent)2019-08-23NDA020378, NDA021211Follitropin Alfa Injectable Solution
follitropin beta Injection
Follitropin Alfa Injection
Follitropin Alfa Pen Injector
6p7741268 (view patent)2024-04-02NDA021684Follitropin Alfa Injectable Solution
follitropin beta Injection
Follitropin Alfa Injection
Follitropin Alfa Pen Injector

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
196f11b5d-cc7b-48aa-830a-a28e1962d871 (view SPL)These highlights do not include all the information needed to use FOLLISTIM AQ Cartridge safely and effectively. See full prescribing information for FOLLISTIM AQ Cartridge. FOLLISTIM AQ Cartridge (follitropin beta injection) for subcutaneous use Initial U.S. Approval: 1997prescriptionHuman PrescriptionOrganon Usa Inc.API MANUFACTURE, MANUFACTURE, PACK2014-12-2213000520313, 000520316, 000520326

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