Ofloxacin Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Cadila Pharmaceuticals Limited (2014-09-24)
Oldest Current Product
2004-01-28
License(s)
ANDA
RxNORM
ORAL TABLET\OFLOXACIN
FDAOB
ORAL\TABLET\OFLOXACIN
SPL Active
ORAL\TABLET, COATED\OFLOXACIN
ORAL\TABLET, FILM COATED\OFLOXACIN
SPL Moiety
ORAL\TABLET, COATED\OFLOXACIN
ORAL\TABLET, FILM COATED\OFLOXACIN

product(s) by strength(s)

ofloxacin 200 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1551110160ANDADr. Reddy'S Laboratories Ltd2006-02-10OFLOXACINORALTABLET, COATEDANDA0770981d19a6db-6da5-e7de-f929-2d18bdfa2cf5
2656910104ANDACadila Pharmaceuticals Limited2014-09-24OFLOXACINORALTABLET, FILM COATEDANDA09165693a464f1-6b54-4f4e-8b71-fa781e2964e6

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1521250141ANDARemedyrepack Inc.2013-03-27OFLOXACINORALTABLET, FILM COATED000937180ANDA076182f5b52c9d-3903-48b7-a821-8f4a35dabc1a

ofloxacin 300 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1551110161ANDADr. Reddy'S Laboratories Ltd2006-02-10OFLOXACINORALTABLET, COATEDANDA0770981d19a6db-6da5-e7de-f929-2d18bdfa2cf5
2656910105ANDACadila Pharmaceuticals Limited2014-09-24OFLOXACINORALTABLET, FILM COATEDANDA09165693a464f1-6b54-4f4e-8b71-fa781e2964e6

ofloxacin 400 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1551110162ANDADr. Reddy'S Laboratories Ltd2006-02-10OFLOXACINORALTABLET, COATEDANDA0770981d19a6db-6da5-e7de-f929-2d18bdfa2cf5
2656910106ANDACadila Pharmaceuticals Limited2014-09-24OFLOXACINORALTABLET, FILM COATEDANDA09165693a464f1-6b54-4f4e-8b71-fa781e2964e6
3680470713ANDALarken Laboratories, Inc.2014-05-20OFLOXACINORALTABLET, FILM COATEDANDA0760936a3dcc79-bde4-4c32-8a0e-ea14a1e1a191

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1430630486ANDAPd-Rx Pharmaceuticals, Inc.2004-01-28OFLOXACINORALTABLET, FILM COATED000937182ANDA076182d3417226-1f42-40cd-82ac-bc31ddf79b97

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076093OFLOXACINLARKEN LABORATORIES INC2003-09-02ANDA076093_001, ANDA076093_002, ANDA076093_003
2ANDA076182OFLOXACINTEVA PHARMACEUTICALS USA INC2003-09-02ANDA076182_001, ANDA076182_002, ANDA076182_003
3ANDA076220OFLOXACINTrueRANBAXY LABORATORIES LTD2003-09-02ANDA076220_001, ANDA076220_002, ANDA076220_003
4ANDA077098OFLOXACINDR REDDYS LABORATORIES LTD2006-02-10ANDA077098_001, ANDA077098_002, ANDA077098_003
5ANDA091656OFLOXACINCADILA PHARMACEUTICALS LTD2014-09-18ANDA091656_001, ANDA091656_002, ANDA091656_003
6NDA019735FLOXINTrueJANSSEN PHARMACEUTICALS INC1990-12-28NDA019735_001, NDA019735_002, NDA019735_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076093_001discontinuedOFLOXACIN (200MG)ORALTABLETFalse2003-09-02OFLOXACIN
2ANDA076093_002discontinuedOFLOXACIN (300MG)ORALTABLETFalse2003-09-02OFLOXACIN
3ANDA076093_003RXOFLOXACIN (400MG)ORALTABLETFalseAB2003-09-02OFLOXACIN
4ANDA076182_001RXOFLOXACIN (200MG)ORALTABLETFalseAB2003-09-02OFLOXACIN
5ANDA076182_002RXOFLOXACIN (300MG)ORALTABLETFalseAB2003-09-02OFLOXACIN
6ANDA076182_003RXOFLOXACIN (400MG)ORALTABLETTrueAB2003-09-02OFLOXACIN
7ANDA076220_001discontinuedOFLOXACIN (200MG)ORALTABLETFalse2003-09-02OFLOXACIN
8ANDA076220_002discontinuedOFLOXACIN (300MG)ORALTABLETFalse2003-09-02OFLOXACIN
9ANDA076220_003discontinuedOFLOXACIN (400MG)ORALTABLETFalse2003-09-02OFLOXACIN
10ANDA077098_001RXOFLOXACIN (200MG)ORALTABLETFalseAB2006-02-10OFLOXACIN
11ANDA077098_002RXOFLOXACIN (300MG)ORALTABLETFalseAB2006-02-10OFLOXACIN
12ANDA077098_003RXOFLOXACIN (400MG)ORALTABLETFalseAB2006-02-10OFLOXACIN
13ANDA091656_001RXOFLOXACIN (200MG)ORALTABLETFalseAB2014-09-18OFLOXACIN
14ANDA091656_002RXOFLOXACIN (300MG)ORALTABLETFalseAB2014-09-18OFLOXACIN
15ANDA091656_003RXOFLOXACIN (400MG)ORALTABLETFalseAB2014-09-18OFLOXACIN
16NDA019735_001discontinuedOFLOXACIN (200MG)ORALTABLETFalse1990-12-28FLOXIN
17NDA019735_002discontinuedOFLOXACIN (300MG)ORALTABLETFalse1990-12-28FLOXIN
18NDA019735_003discontinuedOFLOXACIN (400MG)ORALTABLETFalse1990-12-28FLOXIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11d19a6db-6da5-e7de-f929-2d18bdfa2cf5 (view SPL)OfloxacinprescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2010-01-084551110160, 551110161, 551110162
26a3dcc79-bde4-4c32-8a0e-ea14a1e1a191 (view SPL)OFLOXACIN Tablets, USP Rx OnlyprescriptionHuman PrescriptionLarken Laboratories, Inc.manufacture2015-07-281680470713
393a464f1-6b54-4f4e-8b71-fa781e2964e6 (view SPL)Rx onlyprescriptionHuman PrescriptionCadila Pharmaceuticals LimitedLABEL, MANUFACTURE, PACK2014-09-245656910104, 656910105, 656910106
4d3417226-1f42-40cd-82ac-bc31ddf79b97 (view SPL)OFLOXACIN TABLETS 200 mg, 300 mg, and 400 mg Rx only7180 7181 7182prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2013-08-1911430630486
5f5b52c9d-3903-48b7-a821-8f4a35dabc1a (view SPL)OFLOXACIN TABLETS 200 mg, 300 mg, and 400 mg Rx only7180 7181 7182prescriptionHuman PrescriptionRemedyrepack Inc.2013-03-271521250141

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