letrozole Oral Tablet

Brand(s)
Femara
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2014-01-22)
Oldest Current Product
1997-07-31
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\LETROZOLE
FDAOB
ORAL\TABLET\LETROZOLE
SPL Active
ORAL\TABLET, FILM COATED\LETROZOLE
ORAL\TABLET\LETROZOLE
SPL Moiety
ORAL\TABLET, FILM COATED\LETROZOLE
ORAL\TABLET\LETROZOLE

product(s) by strength(s)

letrozole 2.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780249FemaraNDANovartis Pharmaceuticals Corporation1997-07-31LETROZOLEORALTABLET, FILM COATEDNDA02072682b77d74-085f-45ac-a7dd-1f5c038bf406

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540269ANDARoxane Laboratories, Inc2011-06-03LETROZOLEORALTABLETANDA0908384e92bf71-0ba2-4276-af81-5e61b9122044
2000937620ANDATeva Pharmaceuticals Usa Inc2011-06-03LETROZOLEORALTABLET, FILM COATEDANDA0902898ebda73d-82a3-4b17-8a81-a1f258003d32
3003782071ANDAMylan Pharmaceuticals Inc.2011-04-22LETROZOLEORALTABLET, FILM COATEDANDA0781904818abc4-2797-4248-b7d7-5cb4b5cdcf6a
4005271712ANDALannett Company, Inc.2014-10-29LETROZOLEORALTABLET, FILM COATEDANDA202048eb9ef121-71c7-436f-85d0-aa3649852915
5167290034ANDAAccord Healthcare Inc.2011-06-03LETROZOLEORALTABLET, FILM COATEDANDA090934c391fe11-fd47-4a35-af6d-c823ab7b8838
6247240030ANDAIndicus Pharma Llc2011-06-15LETROZOLEORALTABLETANDA20180487b9906a-1e3f-4bd7-9f93-35d20a386315
7519910759ANDABreckenridge Pharmaceutical, Inc.2011-06-04LETROZOLEORALTABLETANDA20016163e54b62-a30d-4a56-9215-75e7a0b0bf02
8551110646ANDADr. Reddy'S Laboratories Ltd2011-06-03LETROZOLEORALTABLET, FILM COATEDANDA0911916cfd29d7-f519-7b8c-4814-07b39f367f0d
9578842021ANDAJiangsu Hengrui Medicine Co., Ltd.2013-05-16LETROZOLEORALTABLETANDA20271663560663-ecc4-4529-bbd7-c63c1877dfba
10605053255ANDAApotex Corp2012-05-31LETROZOLEORALTABLET, FILM COATEDANDA09130332fd146f-7652-877f-cfd1-db9fa367406a
11621750888ANDAKremers Urban Pharmaceuticals Inc.2011-06-03LETROZOLEORALTABLET, FILM COATEDANDA0910980800d19b-bdd8-47c9-81c3-67a92b81d07a
12627560511ANDASun Pharmaceutical Industries Limited2015-09-09LETROZOLEORALTABLET, FILM COATEDANDA0914666bc22f65-4aaf-40a5-8f36-8b2419249ff5
13633230772ANDAApp Pharmaceuticals, Llc2011-06-04LETROZOLEORALTABLET, FILM COATEDANDA09049113e802e6-3924-4122-ba3a-1966a164c48a

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790169ANDAKaiser Foundations Hospitals2015-02-05LETROZOLEORALTABLET, FILM COATED167290034ANDA090934b275f564-62f8-46de-a290-0b5bdc612988
2422540243ANDARebel Distributors Corp2011-06-03LETROZOLEORALTABLET, FILM COATED000937620ANDA0902890193faa4-9b02-4ccd-9751-de6124cc8c68
3422910374ANDAAvkare, Inc.2015-01-02LETROZOLEORALTABLET, FILM COATED000937620ANDA0902891524730f-e37d-478c-1956-b113b3ca42a8
4548684151FemaraNDAPhysicians Total Care, Inc.2005-02-10LETROZOLEORALTABLET, FILM COATED000780249NDA020726e11b0a54-92bd-4790-8b80-f439f7093c01
5548686252ANDAPhysicians Total Care, Inc.2011-05-04LETROZOLEORALTABLET, FILM COATED003782071ANDA078190b73bf908-7979-4955-af20-0414388920da
6680840803ANDAAmerican Health Packaging2014-08-20LETROZOLEORALTABLET, FILM COATED605053255ANDA091303458f94b4-3ef7-4c73-bad2-017a10a924b6

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA078190LETROZOLEMYLAN PHARMACEUTICALS INC2008-12-24ANDA078190_001
2ANDA090196LETROZOLETrueSYNTHON PHARMACEUTICALS INC2011-06-03ANDA090196_001
3ANDA090289LETROZOLETEVA PHARMACEUTICALS USA2011-06-03ANDA090289_001
4ANDA090292LETROZOLETrueACTAVIS TOTOWA LLC2011-07-13ANDA090292_001
5ANDA090491LETROZOLEFRESENIUS KABI ONCOLOGY PLC2011-06-03ANDA090491_001
6ANDA090789LETROZOLEVINTAGE PHARMACEUTICALS LLC2011-06-03ANDA090789_001
7ANDA090838LETROZOLEROXANE LABORATORIES INC2011-06-03ANDA090838_001
8ANDA090934LETROZOLEACCORD HEALTHCARE INC2011-06-03ANDA090934_001
9ANDA091098LETROZOLEKUDCO IRELAND LTD2011-06-03ANDA091098_001
10ANDA091191LETROZOLEDR REDDYS LABORATORIES LTD2011-06-03ANDA091191_001
11ANDA091303LETROZOLEAPOTEX INC2012-04-19ANDA091303_001
12ANDA091466LETROZOLESUN PHARMACEUTICAL INDUSTRIES LTD2011-06-03ANDA091466_001
13ANDA091638LETROZOLETrueIMPAX LABORATORIES INC2011-06-03ANDA091638_001
14ANDA200161LETROZOLENATCO PHARMA LTD2011-06-03ANDA200161_001
15ANDA201804LETROZOLEINDICUS PHARMA LLC2011-06-03ANDA201804_001
16ANDA202048LETROZOLELANNETT HOLDINGS INC2014-10-29ANDA202048_001
17ANDA202716LETROZOLEJIANGSU HENGRUI MEDICINE CO LTD2013-05-16ANDA202716_001
18NDA020726FEMARANOVARTIS PHARMACEUTICALS CORP1997-07-25NDA020726_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA078190_001RXLETROZOLE (2.5MG)ORALTABLETFalseAB2008-12-24LETROZOLE
2ANDA090196_001discontinuedLETROZOLE (2.5MG)ORALTABLETFalse2011-06-03LETROZOLE
3ANDA090289_001RXLETROZOLE (2.5MG)ORALTABLETFalseAB2011-06-03LETROZOLE
4ANDA090292_001discontinuedLETROZOLE (2.5MG)ORALTABLETFalse2011-07-13LETROZOLE
5ANDA090491_001RXLETROZOLE (2.5MG)ORALTABLETFalseAB2011-06-03LETROZOLE
6ANDA090789_001RXLETROZOLE (2.5MG)ORALTABLETFalseAB2011-06-03LETROZOLE
7ANDA090838_001RXLETROZOLE (2.5MG)ORALTABLETFalseAB2011-06-03LETROZOLE
8ANDA090934_001RXLETROZOLE (2.5MG)ORALTABLETFalseAB2011-06-03LETROZOLE
9ANDA091098_001RXLETROZOLE (2.5MG)ORALTABLETFalseAB2011-06-03LETROZOLE
10ANDA091191_001RXLETROZOLE (2.5MG)ORALTABLETFalseAB2011-06-03LETROZOLE
11ANDA091303_001RXLETROZOLE (2.5MG)ORALTABLETFalseAB2012-04-19LETROZOLE
12ANDA091466_001RXLETROZOLE (2.5MG)ORALTABLETFalseAB2011-06-03LETROZOLE
13ANDA091638_001discontinuedLETROZOLE (2.5MG)ORALTABLETFalse2011-06-03LETROZOLE
14ANDA200161_001RXLETROZOLE (2.5MG)ORALTABLETFalseAB2011-06-03LETROZOLE
15ANDA201804_001RXLETROZOLE (2.5MG)ORALTABLETFalseAB2011-06-03LETROZOLE
16ANDA202048_001RXLETROZOLE (2.5MG)ORALTABLETFalseAB2014-10-29LETROZOLE
17ANDA202716_001RXLETROZOLE (2.5MG)ORALTABLETFalseAB2013-05-16LETROZOLE
18NDA020726_001RXLETROZOLE (2.5MG)ORALTABLETTrueAB1997-07-25FEMARA

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10193faa4-9b02-4ccd-9751-de6124cc8c68 (view SPL)These highlights do not include all the information needed to use letrozole tablets USP safely and effectively. See full prescribing information for letrozole tablets USP. LETROZOLE tablets USP for oral useInitial U.S. Approval: 1997prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-06-201422540243
20800d19b-bdd8-47c9-81c3-67a92b81d07a (view SPL)These highlights do not include all the information needed to use letrozole tablets safely and effectively. See full prescribing information for letrozole tablets. LETROZOLE Tablets, USPInitial U.S. Approval: 1997prescriptionHuman PrescriptionKremers Urban Pharmaceuticals Inc.2011-02-015621750888
313e802e6-3924-4122-ba3a-1966a164c48a (view SPL)These highlights do not include all the information needed to use Letrozole Tablets, USP safely and effectively. See full prescribing information for Letrozole Tablets, USP Letrozole Tablets, USPInitial U.S. Approval: 1997prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2011-06-033633230772
41524730f-e37d-478c-1956-b113b3ca42a8 (view SPL)These highlights do not include all the information needed to use letrozole tablets USP safely and effectively. See full prescribing information for letrozole tablets USP. LETROZOLE tablets USP for oral useInitial U.S. Approval: 1997prescriptionHuman PrescriptionAvkare, Inc.2015-01-021422910374
532fd146f-7652-877f-cfd1-db9fa367406a (view SPL)These highlights do not include all the information needed to use LETROZOLE Tablets, USP safely and effectively.See full prescribing information for LETROZOLE Tablets, USP. LETROZOLE tablets, USP for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2015-03-314605053255
6458f94b4-3ef7-4c73-bad2-017a10a924b6 (view SPL)These highlights do not include all the information needed to use Letrozole Tablets, USP safely and effectively.See full prescribing information for Letrozole Tablets, USP. LETROZOLE Tablets, USP for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-09-111680840803
74818abc4-2797-4248-b7d7-5cb4b5cdcf6a (view SPL)These highlights do not include all the information needed to use letrozole tablets safely and effectively. See full prescribing information for letrozole tablets. LETROZOLE tablets USP, for oral useInitial U.S. Approval: 1997prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-10-304003782071
84e92bf71-0ba2-4276-af81-5e61b9122044 (view SPL)These highlights do not include all the information needed to use LETROZOLE tablets, USP safely and effectively. See full prescribing information for LETROZOLE tablets, USP.LETROZOLE tablets, USP, for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-03-314000540269
963560663-ecc4-4529-bbd7-c63c1877dfba (view SPL)These highlights do not include all the information needed to useLetrozole Tablets USPsafely and effectively. See full prescribing information forLetrozole Tablets USP.Letrozole Tablets USP(Letrozole) Initial U.S. Approval: 1997prescriptionHuman PrescriptionJiangsu Hengrui Medicine Co., Ltd.2015-05-205578842021
1063e54b62-a30d-4a56-9215-75e7a0b0bf02 (view SPL)These highlights do not include all the information needed to use letrozole tablets safely and effectively. See full prescribing information for letrozole tablets.Letrozole tablets USP, 2.5 mgInitial U.S. Approval: 1997prescriptionHuman PrescriptionBreckenridge Pharmaceutical, Inc.MANUFACTURE2011-06-072519910759
116bc22f65-4aaf-40a5-8f36-8b2419249ff5 (view SPL)These highlights do not include all the information needed to use LETROZOLE safely and effectively. See full prescribing information for LETROZOLETABLETS. LETROZOLEtablets, for oral useInitial U.S. Approval: 1997prescriptionHuman PrescriptionSun Pharmaceutical Industries LimitedANALYSIS, MANUFACTURE2015-09-096627560511
126cfd29d7-f519-7b8c-4814-07b39f367f0d (view SPL)These highlights do not include all the information needed to use Letrozole safely and effectively. See full prescribing information for Letrozole Letrozole Tablets USP Initial U.S. Approval: 1997prescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2011-06-034551110646
1382b77d74-085f-45ac-a7dd-1f5c038bf406 (view SPL)These highlights do not include all the information needed to use FEMARA safely and effectively. See full prescribing information for FEMARA. Femara (letrozole) tablets Initial U.S. Approval: 1997prescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2014-01-2216000780249
1487b9906a-1e3f-4bd7-9f93-35d20a386315 (view SPL)These highlights do not include all the information needed to useletrozole tablets safely and effectively. See full prescribing information forletrozole tablets. letrozole tablets USP ,2.5 mg Initial U.S. Approval: 1997prescriptionHuman PrescriptionIndicus Pharma LlcAPI MANUFACTURE, MANUFACTURE2011-07-073247240030
158ebda73d-82a3-4b17-8a81-a1f258003d32 (view SPL)These highlights do not include all the information needed to use letrozole tablets USP safely and effectively. See full prescribing information for letrozole tablets USP. LETROZOLE tablets USP for oral useInitial U.S. Approval: 1997prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2014-03-144000937620
16b275f564-62f8-46de-a290-0b5bdc612988 (view SPL)These highlights do not include all the information needed to use letrozole tablets safely and effectively. See full prescribing information for letrozole tablets. Letrozole Tablets USP Initial U.S. Approval: 1997prescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2015-02-062001790169
17b73bf908-7979-4955-af20-0414388920da (view SPL)These highlights do not include all the information needed to use letrozole safely and effectively. See full prescribing information for letrozole tablets. Letrozole Tablets, USP Initial U.S. Approval: 1997prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2011-05-091548686252
18c391fe11-fd47-4a35-af6d-c823ab7b8838 (view SPL)These highlights do not include all the information needed to use letrozole tablets safely and effectively. See full prescribing information for letrozole tablets. LETROZOLE tablets USP, for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionAccord Healthcare Inc.analysis, manufacture2015-07-174167290034
19e11b0a54-92bd-4790-8b80-f439f7093c01 (view SPL)These highlights do not include all the information needed to useFemara safely and effectively. See full prescribing information forFemara. Femara (letrozole ) ta blets Initial U.S. Approval: 1997prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-01-092548684151
20eb9ef121-71c7-436f-85d0-aa3649852915 (view SPL)These highlights do not include all the information needed to useLetrozole Tablets, USPsafely and effectively. See full prescribing information for Letrozole Tablets, USP. Letrozole Tablets, USP Initial U.S. Approval: 1997prescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-11-049005271712

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