Clarithromycin Oral Suspension

Brand(s)
Biaxin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Zydus Pharmaceuticals (Usa) Inc. (2015-10-23)
Oldest Current Product
1991-10-31
License(s)
NDA, ANDA
RxNORM
ORAL SUSPENSION\CLARITHROMYCIN
FDAOB
ORAL\FOR SUSPENSION\CLARITHROMYCIN
SPL Active
ORAL\FOR SUSPENSION\CLARITHROMYCIN
ORAL\GRANULE, FOR SUSPENSION\CLARITHROMYCIN
SPL Moiety
ORAL\FOR SUSPENSION\CLARITHROMYCIN
ORAL\GRANULE, FOR SUSPENSION\CLARITHROMYCIN

product(s) by strength(s)

clarithromycin 25 mg/ml oral suspension

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1683820764NDAZydus Pharmaceuticals (Usa) Inc.1991-10-31CLARITHROMYCINORALFOR SUSPENSIONNDA05069890d35dd6-a918-c4ab-bc7e-43652ce9b3b4

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007816022ANDASandoz Inc2007-09-04CLARITHROMYCINORALFOR SUSPENSIONANDA06528322457862-0f88-4be8-b507-1c8f264269f2
2633040821ANDARnabaxy Pharmaceuticals Inc.2007-10-03CLARITHROMYCINORALGRANULE, FOR SUSPENSIONANDA06538294c182ed-f2d6-4f7f-bdd9-69b136c54623

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684919BiaxinNDAPhysicians Total Care, Inc.2003-12-032011-06-30CLARITHROMYCINORALGRANULE, FOR SUSPENSION000743163NDA0506982e899f4a-a2e9-445c-a0ed-6ad811e997e6

clarithromycin 50 mg/ml oral suspension

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1683820765NDAZydus Pharmaceuticals (Usa) Inc.1991-10-31CLARITHROMYCINORALFOR SUSPENSIONNDA05069890d35dd6-a918-c4ab-bc7e-43652ce9b3b4

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007816023ANDASandoz Inc2007-09-04CLARITHROMYCINORALFOR SUSPENSIONANDA06528322457862-0f88-4be8-b507-1c8f264269f2
2633040822ANDARnabaxy Pharmaceuticals Inc.2007-10-03CLARITHROMYCINORALGRANULE, FOR SUSPENSIONANDA06538294c182ed-f2d6-4f7f-bdd9-69b136c54623

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548680654ANDAPhysicians Total Care, Inc.2008-03-04CLARITHROMYCINORALFOR SUSPENSION007816023ANDA065283903939b3-a01d-4593-85ca-cfe8d4d48d3e
2548683384BiaxinNDAPhysicians Total Care, Inc.2007-05-01CLARITHROMYCINORALGRANULE, FOR SUSPENSION000743188NDA0506982e899f4a-a2e9-445c-a0ed-6ad811e997e6

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA065283CLARITHROMYCINSANDOZ INC2007-09-04ANDA065283_002, ANDA065283_003
2ANDA065382CLARITHROMYCINSUN PHARMACEUTICAL INDUSTRIES LTD2007-08-30ANDA065382_001, ANDA065382_002
3NDA050698BIAXINABBVIE INC1993-12-23NDA050698_001, NDA050698_002, NDA050698_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA065283_002RXCLARITHROMYCIN (125MG/5ML)ORALFOR SUSPENSIONFalseAB2007-09-04CLARITHROMYCIN
2ANDA065283_003RXCLARITHROMYCIN (250MG/5ML)ORALFOR SUSPENSIONFalseAB2007-09-04CLARITHROMYCIN
3ANDA065382_001RXCLARITHROMYCIN (125MG/5ML)ORALFOR SUSPENSIONFalseAB2007-08-30CLARITHROMYCIN
4ANDA065382_002RXCLARITHROMYCIN (250MG/5ML)ORALFOR SUSPENSIONFalseAB2007-08-30CLARITHROMYCIN
5NDA050698_001RXCLARITHROMYCIN (125MG/5ML)ORALFOR SUSPENSIONFalseAB1993-12-23BIAXIN
6NDA050698_002RXCLARITHROMYCIN (250MG/5ML)ORALFOR SUSPENSIONTrueAB1993-12-23BIAXIN
7NDA050698_003discontinuedCLARITHROMYCIN (187MG/5ML)ORALFOR SUSPENSIONFalse1998-09-30BIAXIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
122457862-0f88-4be8-b507-1c8f264269f2 (view SPL)Clarithromycin for Oral Suspension, USPprescriptionHuman PrescriptionSandoz Inc2015-01-219007816022, 007816023
22e899f4a-a2e9-445c-a0ed-6ad811e997e6 (view SPL)BIAXIN Filmtab(clarithromycin tablets, USP)BIAXIN XL Filmtab(clarithromycin extended-release tablets)BIAXIN Granules(clarithromycin for oral suspension, USP)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-02-221548683384, 548684919, 548682338, 548683820, 548684191Clarithromycin Extended Release Oral Tablet
Clarithromycin Oral Tablet
3903939b3-a01d-4593-85ca-cfe8d4d48d3e (view SPL)Clarithromycin for Oral Suspension, USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2014-04-117548680654
490d35dd6-a918-c4ab-bc7e-43652ce9b3b4 (view SPL)CLARITHROMYCIN TABLETS, USPCLARITHROMYCIN FOR ORAL SUSPENSION, USPCLARITHROMYCIN EXTENDED-RELEASE TABLETSprescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.2015-10-2365683820764, 683820765, 683820761, 683820762, 683820763Clarithromycin Extended Release Oral Tablet
Clarithromycin Oral Tablet
594c182ed-f2d6-4f7f-bdd9-69b136c54623 (view SPL)CLARITHROMYCIN TABLETS, USP AND CLARITHROMYCIN FOR ORAL SUSPENSION, USPRx onlyprescriptionHuman PrescriptionRnabaxy Pharmaceuticals Inc.FDF MANUFACTURE, api manufacture2013-10-244633040821, 633040822, 633040725, 633040726Clarithromycin Oral Tablet
6aa44552c-3cfe-4111-8aa5-4251aeed9be9 (view SPL)BIAXIN Filmtab(clarithromycin tablets, USP)BIAXIN XL Filmtab(clarithromycin extended-release tablets)BIAXIN Granules(clarithromycin for oral suspension, USP)prescriptionHuman PrescriptionAbbvie Inc.2015-10-271531000742586, 000743163, 000743165, 000743188, 000743368Clarithromycin Extended Release Oral Tablet
Clarithromycin Oral Tablet

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