famciclovir Oral Tablet

Brand(s)
Famvir
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2013-04-29)
Oldest Current Product
1994-06-29
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\FAMCICLOVIR
FDAOB
ORAL\TABLET\FAMCICLOVIR
SPL Active
ORAL\TABLET, FILM COATED\FAMCICLOVIR
ORAL\TABLET\FAMCICLOVIR
SPL Moiety
ORAL\TABLET, FILM COATED\FAMCICLOVIR
ORAL\TABLET, FILM COATED\FAMCICLOVIR: PENCICLOVIR
ORAL\TABLET, FILM COATED\PENCICLOVIR
ORAL\TABLET\PENCICLOVIR

product(s) by strength(s)

famciclovir 125 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780366FamvirNDANovartis Pharmaceuticals Corporation1994-06-29FAMCICLOVIRORALTABLET, FILM COATEDNDA0203633c6194c0-ba69-4b16-b882-caf736a02348

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540196ANDARoxane Laboratories, Inc2011-01-03FAMCICLOVIRORALTABLETANDA0901283cd2e7f1-cbdb-47f6-b37f-830aaaef2482
2000938117ANDATeva Pharmaceuticals Usa Inc2007-09-05FAMCICLOVIRORALTABLET, FILM COATEDANDA0774873f02042f-8f51-4ccf-b608-5dcd75d100fb
3003784490ANDAMylan Pharmaceuticals Inc.2011-04-18FAMCICLOVIRORALTABLET, FILM COATEDANDA201333e563b079-a892-4505-a4ab-e6c9c8c02a51
4005913271ANDAWatson Laboratories, Inc.2011-03-21FAMCICLOVIRORALTABLET, FILM COATEDANDA078278c5617ff1-33a1-4d50-9b1c-e3fc4767f373
5167140300ANDANorthstar Rx Llc2011-03-21FAMCICLOVIRORALTABLET, FILM COATEDANDA0911149bced3c4-f450-4e21-9baa-ab2efd0ed4bd
6317220706ANDACamber Pharmaceuticals, Inc.2014-09-10FAMCICLOVIRORALTABLET, FILM COATEDANDA20243808c58224-5920-4853-8c59-ec5fbb66c2f6
7333420024ANDAMacleods Pharmaceuticals Limited2011-12-17FAMCICLOVIRORALTABLET, FILM COATEDANDA201022eeeee9c4-8566-4100-8ca4-3df936a3365d
8605053245ANDAApotex Corp2011-12-20FAMCICLOVIRORALTABLET, FILM COATEDANDA091480a5c46194-3692-cd26-0d85-6371974ccc44
9658620465ANDAAurobindo Pharma Limited2011-03-21FAMCICLOVIRORALTABLET, FILM COATEDANDA091114fcf0b0fa-bb2c-4f2c-aa9f-1f2da65d8343
10690970269ANDACipla Usa Inc.2011-03-21FAMCICLOVIRORALTABLETANDA078278ac7cfbb0-5658-49f4-b828-81389c590448

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910275ANDAAvkare, Inc.2012-01-04FAMCICLOVIRORALTABLET, FILM COATED000938117ANDA0774879f2714cd-0a45-235c-7490-747a9af67471
2502680305ANDAAvpak2013-05-16FAMCICLOVIRORALTABLET, FILM COATED333420024ANDA2010220359a546-036b-a1d7-d32c-cd9137d82257
3604290359ANDAGolden State Medical Supply, Inc.2011-12-20FAMCICLOVIRORALTABLET, FILM COATED605053245ANDA0914805c133dfe-3cb5-426b-ac30-daf814e12c47

famciclovir 250 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780367FamvirNDANovartis Pharmaceuticals Corporation1994-06-29FAMCICLOVIRORALTABLET, FILM COATEDNDA0203633c6194c0-ba69-4b16-b882-caf736a02348

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540197ANDARoxane Laboratories, Inc2011-01-03FAMCICLOVIRORALTABLETANDA0901283cd2e7f1-cbdb-47f6-b37f-830aaaef2482
2000938118ANDATeva Pharmaceuticals Usa Inc2007-09-05FAMCICLOVIRORALTABLET, FILM COATEDANDA0774873f02042f-8f51-4ccf-b608-5dcd75d100fb
3003784491ANDAMylan Pharmaceuticals Inc.2011-04-18FAMCICLOVIRORALTABLET, FILM COATEDANDA201333e563b079-a892-4505-a4ab-e6c9c8c02a51
4005913272ANDAWatson Laboratories, Inc.2011-03-21FAMCICLOVIRORALTABLET, FILM COATEDANDA078278c5617ff1-33a1-4d50-9b1c-e3fc4767f373
5167140304ANDANorthstar Rx Llc2011-03-21FAMCICLOVIRORALTABLET, FILM COATEDANDA0911149bced3c4-f450-4e21-9baa-ab2efd0ed4bd
6317220707ANDACamber Pharmaceuticals, Inc.2014-09-10FAMCICLOVIRORALTABLET, FILM COATEDANDA20243808c58224-5920-4853-8c59-ec5fbb66c2f6
7333420025ANDAMacleods Pharmaceuticals Limited2011-12-17FAMCICLOVIRORALTABLET, FILM COATEDANDA201022eeeee9c4-8566-4100-8ca4-3df936a3365d
8605053246ANDAApotex Corp2011-12-20FAMCICLOVIRORALTABLET, FILM COATEDANDA091480a5c46194-3692-cd26-0d85-6371974ccc44
9658620466ANDAAurobindo Pharma Limited2011-03-21FAMCICLOVIRORALTABLET, FILM COATEDANDA091114fcf0b0fa-bb2c-4f2c-aa9f-1f2da65d8343

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910276ANDAAvkare, Inc.2012-01-04FAMCICLOVIRORALTABLET, FILM COATED000938118ANDA0774879f2714cd-0a45-235c-7490-747a9af67471
2502680306ANDAAvpak2013-05-16FAMCICLOVIRORALTABLET, FILM COATED333420025ANDA2010220359a546-036b-a1d7-d32c-cd9137d82257
3604290360ANDAGolden State Medical Supply, Inc.2011-12-20FAMCICLOVIRORALTABLET, FILM COATED605053246ANDA0914805c133dfe-3cb5-426b-ac30-daf814e12c47

famciclovir 500 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780368FamvirNDANovartis Pharmaceuticals Corporation1994-06-29FAMCICLOVIRORALTABLET, FILM COATEDNDA0203633c6194c0-ba69-4b16-b882-caf736a02348

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540198ANDARoxane Laboratories, Inc2011-01-03FAMCICLOVIRORALTABLETANDA0901283cd2e7f1-cbdb-47f6-b37f-830aaaef2482
2000938119ANDATeva Pharmaceuticals Usa Inc2007-09-05FAMCICLOVIRORALTABLET, FILM COATEDANDA0774873f02042f-8f51-4ccf-b608-5dcd75d100fb
3003784492ANDAMylan Pharmaceuticals Inc.2011-04-18FAMCICLOVIRORALTABLET, FILM COATEDANDA201333e563b079-a892-4505-a4ab-e6c9c8c02a51
4005913273ANDAWatson Laboratories, Inc.2011-03-21FAMCICLOVIRORALTABLET, FILM COATEDANDA078278c5617ff1-33a1-4d50-9b1c-e3fc4767f373
5167140305ANDANorthstar Rx Llc2011-03-21FAMCICLOVIRORALTABLET, FILM COATEDANDA0911149bced3c4-f450-4e21-9baa-ab2efd0ed4bd
6317220708ANDACamber Pharmaceuticals, Inc.2014-09-10FAMCICLOVIRORALTABLET, FILM COATEDANDA20243808c58224-5920-4853-8c59-ec5fbb66c2f6
7333420026ANDAMacleods Pharmaceuticals Limited2011-12-17FAMCICLOVIRORALTABLET, FILM COATEDANDA201022eeeee9c4-8566-4100-8ca4-3df936a3365d
8605053247ANDAApotex Corp2011-12-20FAMCICLOVIRORALTABLET, FILM COATEDANDA091480a5c46194-3692-cd26-0d85-6371974ccc44
9658620467ANDAAurobindo Pharma Limited2011-03-21FAMCICLOVIRORALTABLET, FILM COATEDANDA091114fcf0b0fa-bb2c-4f2c-aa9f-1f2da65d8343

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910277ANDAAvkare, Inc.2012-01-04FAMCICLOVIRORALTABLET, FILM COATED000938119ANDA0774879f2714cd-0a45-235c-7490-747a9af67471
2502680307ANDAAvpak2013-05-16FAMCICLOVIRORALTABLET, FILM COATED333420026ANDA2010220359a546-036b-a1d7-d32c-cd9137d82257
3548685905ANDAPhysicians Total Care, Inc.2008-06-16FAMCICLOVIRORALTABLET, FILM COATED000938119ANDA077487405372a1-83bc-4843-b1b2-bd8ff2f83f87
4552890168ANDAPd-Rx Pharmaceuticals, Inc.2011-04-01FAMCICLOVIRORALTABLET, FILM COATED000938119ANDA0774872c44b8d2-3b70-4e8b-af03-2e917178f761
5604290361ANDAGolden State Medical Supply, Inc.2011-12-20FAMCICLOVIRORALTABLET, FILM COATED605053247ANDA0914805c133dfe-3cb5-426b-ac30-daf814e12c47
6606870103ANDAAmerican Health Packaging2015-03-31FAMCICLOVIRORALTABLET, FILM COATED605053247ANDA091480747a5b5b-fe25-4c78-a9cc-662ebffc3183

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1ANDA077487FAMCICLOVIRTEVA PHARMACEUTICALS USA2007-08-24ANDA077487_001, ANDA077487_002, ANDA077487_003
2ANDA078278FAMCICLOVIRCIPLA LTD2011-03-21ANDA078278_001, ANDA078278_002, ANDA078278_003
3ANDA090128FAMCICLOVIRROXANE LABORATORIES INC2011-03-21ANDA090128_001, ANDA090128_002, ANDA090128_003
4ANDA091114FAMCICLOVIRAUROBINDO PHARMA LTD2011-03-21ANDA091114_001, ANDA091114_002, ANDA091114_003
5ANDA091480FAMCICLOVIRAPOTEX INC2011-07-22ANDA091480_001, ANDA091480_002, ANDA091480_003
6ANDA201022FAMCICLOVIRMACLEODS PHARMACEUTICALS LTD2012-01-12ANDA201022_001, ANDA201022_002, ANDA201022_003
7ANDA201333FAMCICLOVIRMYLAN PHARMACEUTICALS INC2011-03-24ANDA201333_001, ANDA201333_002, ANDA201333_003
8ANDA202438FAMCICLOVIRHETERO LABS LTD UNIT V2014-09-10ANDA202438_001, ANDA202438_002, ANDA202438_003
9NDA020363FAMVIRNOVARTIS PHARMACEUTICALS CORP1994-06-29p6124304, METHOD OF TREATING VARICELLA ZOSTER (SHINGLES) INFECTIONS
p5840763, METHOD OF TREATING VARICELLA ZOSTER (SHINGLES) INFECTIONS
p5866581, METHOD OF TREATING VARICELLA ZOSTER (SHINGLES) INFECTIONS
p5916893, METHOD OF TREATING VARICELLA ZOSTER (SHINGLES) INFECTIONS
REVISIONS TO THE PEDIATRIC USE SECTION OF THE PACKAGE INSERT TO ADD INFORMATION FROM A PEDIATRIC STUDY IN PATIENTS AGED 12 YEARS TO LESS THAN 18 YEARS OF AGE WITH RECURRENT HERPES LABIALIS [2015-02-09]NDA020363_001, NDA020363_002, NDA020363_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077487_001RXFAMCICLOVIR (125MG)ORALTABLETFalseAB2007-08-24FAMCICLOVIR
2ANDA077487_002RXFAMCICLOVIR (250MG)ORALTABLETFalseAB2007-08-24FAMCICLOVIR
3ANDA077487_003RXFAMCICLOVIR (500MG)ORALTABLETFalseAB2007-08-24FAMCICLOVIR
4ANDA078278_001RXFAMCICLOVIR (125MG)ORALTABLETFalseAB2011-03-21FAMCICLOVIR
5ANDA078278_002RXFAMCICLOVIR (250MG)ORALTABLETFalseAB2011-03-21FAMCICLOVIR
6ANDA078278_003RXFAMCICLOVIR (500MG)ORALTABLETFalseAB2011-03-21FAMCICLOVIR
7ANDA090128_001RXFAMCICLOVIR (125MG)ORALTABLETFalseAB2011-03-21FAMCICLOVIR
8ANDA090128_002RXFAMCICLOVIR (250MG)ORALTABLETFalseAB2011-03-21FAMCICLOVIR
9ANDA090128_003RXFAMCICLOVIR (500MG)ORALTABLETFalseAB2011-03-21FAMCICLOVIR
10ANDA091114_001RXFAMCICLOVIR (125MG)ORALTABLETFalseAB2011-03-21FAMCICLOVIR
11ANDA091114_002RXFAMCICLOVIR (250MG)ORALTABLETFalseAB2011-03-21FAMCICLOVIR
12ANDA091114_003RXFAMCICLOVIR (500MG)ORALTABLETFalseAB2011-03-21FAMCICLOVIR
13ANDA091480_001RXFAMCICLOVIR (125MG)ORALTABLETFalseAB2011-07-22FAMCICLOVIR
14ANDA091480_002RXFAMCICLOVIR (250MG)ORALTABLETFalseAB2011-07-22FAMCICLOVIR
15ANDA091480_003RXFAMCICLOVIR (500MG)ORALTABLETFalseAB2011-07-22FAMCICLOVIR
16ANDA201022_001RXFAMCICLOVIR (125MG)ORALTABLETFalseAB2012-01-12FAMCICLOVIR
17ANDA201022_002RXFAMCICLOVIR (250MG)ORALTABLETFalseAB2012-01-12FAMCICLOVIR
18ANDA201022_003RXFAMCICLOVIR (500MG)ORALTABLETFalseAB2012-01-12FAMCICLOVIR
19ANDA201333_001RXFAMCICLOVIR (125MG)ORALTABLETFalseAB2011-03-24FAMCICLOVIR
20ANDA201333_002RXFAMCICLOVIR (250MG)ORALTABLETFalseAB2011-03-24FAMCICLOVIR
21ANDA201333_003RXFAMCICLOVIR (500MG)ORALTABLETFalseAB2011-03-24FAMCICLOVIR
22ANDA202438_001RXFAMCICLOVIR (125MG)ORALTABLETFalseAB2014-09-10FAMCICLOVIR
23ANDA202438_002RXFAMCICLOVIR (250MG)ORALTABLETFalseAB2014-09-10FAMCICLOVIR
24ANDA202438_003RXFAMCICLOVIR (500MG)ORALTABLETFalseAB2014-09-10FAMCICLOVIR
25NDA020363_001RXFAMCICLOVIR (250MG)ORALTABLETFalseAB1996-04-26FAMVIR
26NDA020363_002RXFAMCICLOVIR (500MG)ORALTABLETTrueAB1994-06-29FAMVIR
27NDA020363_003RXFAMCICLOVIR (125MG)ORALTABLETFalseAB1995-12-11FAMVIR

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5840763 (view patent)2015-09-01NDA020363, NDA020629penciclovir Topical Cream
2p5866581 (view patent)2014-10-04NDA020363, NDA020629penciclovir Topical Cream
3p5916893 (view patent)2015-09-01NDA020363, NDA020629penciclovir Topical Cream
4p6124304 (view patent)2014-10-04NDA020363, NDA020629penciclovir Topical Cream

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10359a546-036b-a1d7-d32c-cd9137d82257 (view SPL)These highlights do not include all the information needed to use Famciclovir Tablets safely and effectively. See full prescribing information for Famciclovir Tablets. Famciclovir TabletsInitial U.S. Approval: 1994prescriptionHuman PrescriptionAvpak2014-09-234502680305, 502680306, 502680307
208c58224-5920-4853-8c59-ec5fbb66c2f6 (view SPL)These highlights do not include all the information needed to use famciclovir safely and effectively. See full prescribing information for famciclovir. FAMCICLOVIR tablet, for oral useInitial U.S. Approval: 1994prescriptionHuman PrescriptionCamber Pharmaceuticals, Inc.2014-02-041317220706, 317220707, 317220708
32c44b8d2-3b70-4e8b-af03-2e917178f761 (view SPL)These highlights do not include all the information needed to use famciclovir tablets safely and effectively. See full prescribing information for famciclovir tablets.FAMCICLOVIR tablets for oral use Initial U.S. Approval: 1994prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-04-145552890168
43c6194c0-ba69-4b16-b882-caf736a02348 (view SPL)These highlights do not include all the information needed to use FAMVIR safely and effectively. See full prescribing information for FAMVIR. FAMVIR (famciclovir) t ablets Initial U.S. Approval: 1994prescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2013-04-2914000780366, 000780367, 000780368
53cd2e7f1-cbdb-47f6-b37f-830aaaef2482 (view SPL)These highlights do not include all the information needed to use Famciclovir Tablets safely and effectively. See full prescribing information for Famciclovir Tablets. Initial U.S. Approval: 1994prescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-03-095000540196, 000540197, 000540198
63f02042f-8f51-4ccf-b608-5dcd75d100fb (view SPL)These highlights do not include all the information needed to use Famciclovir Tablets safely and effectively. See full prescribing information for Famciclovir Tablets.FAMCICLOVIR Tablets for oral use Initial U.S. Approval: 1994prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-04-289000938117, 000938118, 000938119
7405372a1-83bc-4843-b1b2-bd8ff2f83f87 (view SPL)These highlights do not include all the information needed to use famciclovir tablets safely and effectively. See full prescribing information for famciclovir tablets.FAMCICLOVIR tablets for oral use Initial U.S. Approval: 1994prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-12-223548685905
85c133dfe-3cb5-426b-ac30-daf814e12c47 (view SPL)These highlights do not include all the information needed to use FAMCICLOVIR Tablets safely and effectively. See full prescribing information for FAMCICLOVIR Tablets. FAMCICLOVIR TabletsInitial U.S. Approval: 1994prescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2012-01-091604290359, 604290360, 604290361
9747a5b5b-fe25-4c78-a9cc-662ebffc3183 (view SPL)These highlights do not include all the information needed to use famciclovir tablets safely and effectively. See full prescribing information for famciclovir tablets. FAMCICLOVIR tablets for oral useInitial U.S. Approval: 1994prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-09-172606870103
109bced3c4-f450-4e21-9baa-ab2efd0ed4bd (view SPL)These highlights do not include all the information needed to use famciclovir tablets safely and effectively. See full prescribing information for famciclovir tablets.FAMCICLOVIR tablets, for oral useInitial U.S. Approval: 1994prescriptionHuman PrescriptionNorthstar Rx LlcANALYSIS, API MANUFACTURE, MANUFACTURE2015-04-285167140300, 167140304, 167140305
119f2714cd-0a45-235c-7490-747a9af67471 (view SPL)These highlights do not include all the information needed to use Famciclovir Tablets safely and effectively. See full prescribing information for Famciclovir Tablets.FAMCICLOVIR Tablets for oral use Initial U.S. Approval: 1994prescriptionHuman PrescriptionAvkare, Inc.2015-03-186422910275, 422910276, 422910277
12a5c46194-3692-cd26-0d85-6371974ccc44 (view SPL)These highlights do not include all the information needed to use FAMCICLOVIR TABLETS safely and effectively. See full prescribing information for FAMCICLOVIR TABLETS. FAMCICLOVIR tablets for oral use Initial U.S. Approval: 1994prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2015-09-018605053245, 605053246, 605053247
13ac7cfbb0-5658-49f4-b828-81389c590448 (view SPL)These highlights do not include all the information needed to use FAMCICLOVIR tablets safely and effectively. See full prescribing information for FAMCICLOVIR tablets. FAMCICLOVIR tablets, for oral use.Initial U.S. Approval: 1994prescriptionHuman PrescriptionCipla Usa Inc.api manufacture, manufacture2015-07-102690970269
14c5617ff1-33a1-4d50-9b1c-e3fc4767f373 (view SPL)These highlights do not include all the information needed to useFAMCICLOVIR TABLETS safely and effectively. See full prescribing information for FAMCICLOVIR TABLETS. FAMCICLOVIR TABLETS Initial U.S. Approval: 1994prescriptionHuman PrescriptionWatson Laboratories, Inc.MANUFACTURE2015-02-0114005913271, 005913272, 005913273
15e563b079-a892-4505-a4ab-e6c9c8c02a51 (view SPL)These highlights do not include all the information needed to use famciclovir tablets safely and effectively. See full prescribing information for famciclovir tablets. FAMCICLOVIR tablets, for oral use Initial U.S. Approval: 1994prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-04-157003784490, 003784491, 003784492
16eeeee9c4-8566-4100-8ca4-3df936a3365d (view SPL)These highlights do not include all the information needed to use FAMCICLOVIR Tablets safely and effectively. See full prescribing information for FAMCICLOVIR Tablets.FAMCICLOVIR Tablets for oral useInitial U.S. Approval: 1994prescriptionHuman PrescriptionMacleods Pharmaceuticals Limited2014-02-015333420024, 333420025, 333420026
17fcf0b0fa-bb2c-4f2c-aa9f-1f2da65d8343 (view SPL)These highlights do not include all the information needed to use famciclovir tablets safely and effectively. See full prescribing information for famciclovir tablets.FAMCICLOVIR tablets, for oral useInitial U.S. Approval: 1994prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2015-03-0511658620465, 658620466, 658620467

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