cefprozil Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Lupin Pharmaceuticals, Inc. (2012-11-06)
Oldest Current Product
2005-11-14
License(s)
ANDA
RxNORM
ORAL TABLET\CEFPROZIL
FDAOB
ORAL\TABLET\CEFPROZIL
SPL Active
ORAL\TABLET, FILM COATED\CEFPROZIL
ORAL\TABLET\CEFPROZIL
SPL Moiety
ORAL\TABLET, FILM COATED\CEFPROZIL ANHYDROUS
ORAL\TABLET\CEFPROZIL ANHYDROUS

product(s) by strength(s)

cefprozil 250 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000931077ANDATeva Pharmaceuticals Usa Inc2005-12-23CEFPROZILORALTABLET, FILM COATEDANDA0652083391de8b-7bc9-4624-a5c4-836135b39d99
2007815043ANDASandoz Inc2005-11-14CEFPROZILORALTABLET, FILM COATEDANDA065235a547cc0a-6af0-49c7-a5ea-c41684cc36ae
3167140398ANDANorthstar Rx Llc2007-05-24CEFPROZILORALTABLET, FILM COATEDANDA0653406133611e-19c1-4df2-8c23-8573aaf63020
4556480712ANDAWockhardt Limited2007-06-15CEFPROZILORALTABLET, FILM COATEDANDA065428225011b9-0f3a-4afc-ac80-bd1f3739bb3b
5572370036ANDACitron Pharma Llc2007-05-24CEFPROZILORALTABLET, FILM COATEDANDA065340af24a86f-8072-49a6-94ec-2f17fe81812b
6605052532ANDAApotex Corp2008-05-09CEFPROZILORALTABLET, FILM COATEDANDA0653271bb0b9d8-278e-6a25-9b29-d8193f41a77b
7646790712ANDAWockhardt Usa Llc.2007-06-15CEFPROZILORALTABLET, FILM COATEDANDA065428f85f23ef-a73f-47f7-8283-8dab1afdc792
8658620068ANDAAurobindo Pharma Limited2007-05-24CEFPROZILORALTABLET, FILM COATEDANDA065340b9111a81-07c4-4458-b994-a4ad504986d8
9672530231ANDADava Pharmaceuticals, Inc.2014-08-01CEFPROZILORALTABLET, FILM COATEDANDA065235d2dbfc48-063b-41c0-864c-2c9426ba89c1
10681800403ANDALupin Pharmaceuticals, Inc.2005-12-01CEFPROZILORALTABLETANDA06527614527f4a-ce99-449d-a5a5-9edd7fb28dee

cefprozil 500 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000931078ANDATeva Pharmaceuticals Usa Inc2005-12-23CEFPROZILORALTABLET, FILM COATEDANDA0652083391de8b-7bc9-4624-a5c4-836135b39d99
2007815044ANDASandoz Inc2005-11-14CEFPROZILORALTABLET, FILM COATEDANDA065235a547cc0a-6af0-49c7-a5ea-c41684cc36ae
3167140399ANDANorthstar Rx Llc2007-05-24CEFPROZILORALTABLET, FILM COATEDANDA0653406133611e-19c1-4df2-8c23-8573aaf63020
4572370037ANDACitron Pharma Llc2007-05-24CEFPROZILORALTABLET, FILM COATEDANDA065340af24a86f-8072-49a6-94ec-2f17fe81812b
5605052533ANDAApotex Corp2008-05-09CEFPROZILORALTABLET, FILM COATEDANDA0653271bb0b9d8-278e-6a25-9b29-d8193f41a77b
6658620069ANDAAurobindo Pharma Limited2007-05-24CEFPROZILORALTABLET, FILM COATEDANDA065340b9111a81-07c4-4458-b994-a4ad504986d8
7672530232ANDADava Pharmaceuticals, Inc.2014-08-01CEFPROZILORALTABLET, FILM COATEDANDA065235d2dbfc48-063b-41c0-864c-2c9426ba89c1

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1458650716ANDAMedsource Pharmaceuticals2007-05-24CEFPROZILORALTABLET, FILM COATED572370037ANDA0653401fbe6b78-80fe-223b-e054-00144ff88e88
2529590300ANDAH.J. Harkins Company, Inc.2005-12-08CEFPROZILORALTABLET681800404ANDA06527617a1975e-ce3b-4057-ae5b-8d191319caa7
3548685756ANDAPhysicians Total Care, Inc.2007-02-05CEFPROZILORALTABLET681800404ANDA06527675d57e35-ffeb-4d88-8dba-5458e284fd82
4672960590ANDARedpharm Drug Inc.2005-12-08CEFPROZILORALTABLET681800404ANDA0652760f96e4fe-8daf-492b-8fd8-90ff25243077

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA065198CEFPROZILTrueRANBAXY LABORATORIES LTD2006-12-13ANDA065198_001, ANDA065198_002
2ANDA065208CEFPROZILTEVA PHARMACEUTICALS USA INC2005-12-06ANDA065208_001, ANDA065208_002
3ANDA065235CEFPROZILSANDOZ INC2005-11-14ANDA065235_001, ANDA065235_002
4ANDA065267CEFPROZILORCHID HEALTHCARE2005-12-19ANDA065267_001, ANDA065267_002
5ANDA065276CEFPROZILLUPIN LTD2005-12-08ANDA065276_001, ANDA065276_002
6ANDA065327CEFPROZILAPOTEX INC2008-03-26ANDA065327_001, ANDA065327_002
7ANDA065340CEFPROZILAUROBINDO PHARMA LTD INC2007-05-24ANDA065340_001, ANDA065340_002
8ANDA065428CEFPROZILWOCKHARDT LTD2007-06-14ANDA065428_001, ANDA065428_002
9NDA050664CEFZILTrueCORDEN PHARMA LATINA SPA1991-12-23NDA050664_001, NDA050664_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA065198_001discontinuedCEFPROZIL (250MG)ORALTABLETFalse2006-12-13CEFPROZIL
2ANDA065198_002discontinuedCEFPROZIL (500MG)ORALTABLETFalse2006-12-13CEFPROZIL
3ANDA065208_001RXCEFPROZIL (250MG)ORALTABLETFalseAB2005-12-06CEFPROZIL
4ANDA065208_002RXCEFPROZIL (500MG)ORALTABLETFalseAB2005-12-06CEFPROZIL
5ANDA065235_001RXCEFPROZIL (250MG)ORALTABLETFalseAB2005-11-14CEFPROZIL
6ANDA065235_002RXCEFPROZIL (500MG)ORALTABLETFalseAB2005-11-14CEFPROZIL
7ANDA065267_001RXCEFPROZIL (250MG)ORALTABLETFalseAB2005-12-19CEFPROZIL
8ANDA065267_002RXCEFPROZIL (500MG)ORALTABLETFalseAB2005-12-19CEFPROZIL
9ANDA065276_001RXCEFPROZIL (250MG)ORALTABLETFalseAB2005-12-08CEFPROZIL
10ANDA065276_002RXCEFPROZIL (500MG)ORALTABLETTrueAB2005-12-08CEFPROZIL
11ANDA065327_001RXCEFPROZIL (250MG)ORALTABLETFalseAB2008-03-26CEFPROZIL
12ANDA065327_002RXCEFPROZIL (500MG)ORALTABLETFalseAB2008-03-26CEFPROZIL
13ANDA065340_001RXCEFPROZIL (250MG)ORALTABLETFalseAB2007-05-24CEFPROZIL
14ANDA065340_002RXCEFPROZIL (500MG)ORALTABLETFalseAB2007-05-24CEFPROZIL
15ANDA065428_001RXCEFPROZIL (250MG)ORALTABLETFalseAB2007-06-14CEFPROZIL
16ANDA065428_002RXCEFPROZIL (500MG)ORALTABLETFalseAB2007-06-14CEFPROZIL
17NDA050664_001discontinuedCEFPROZIL (250MG)ORALTABLETFalse1991-12-23CEFZIL
18NDA050664_002discontinuedCEFPROZIL (500MG)ORALTABLETFalse1991-12-23CEFZIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
10f96e4fe-8daf-492b-8fd8-90ff25243077 (view SPL)Cefprozil TabletsprescriptionHuman PrescriptionRedpharm Drug Inc.manufacture2011-07-072672960590
214527f4a-ce99-449d-a5a5-9edd7fb28dee (view SPL)CEFPROZIL TABLETS USP 250 mg and 500 mgRx onlyprescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.2012-11-063681800403
317a1975e-ce3b-4057-ae5b-8d191319caa7 (view SPL)CEFPROZIL TABLETS USP 250 mg and 500 mgRx onlyprescriptionHuman PrescriptionH.J. Harkins Company, Inc.manufacture2011-11-153529590300
41bb0b9d8-278e-6a25-9b29-d8193f41a77b (view SPL)Cefprozil Tablets USP 250 mg and 500 mgprescriptionHuman PrescriptionApotex Corpanalysis, manufacture2012-09-281605052532, 605052533
51fbe6b78-80fe-223b-e054-00144ff88e88 (view SPL)prescriptionHuman PrescriptionMedsource Pharmaceuticalsrepack2015-09-141458650716
6225011b9-0f3a-4afc-ac80-bd1f3739bb3b (view SPL)Cefprozil Tablets USP, 250 mg and 500 mgprescriptionHuman PrescriptionWockhardt LimitedANALYSIS, LABEL, MANUFACTURE, PACK2012-08-281556480712
73391de8b-7bc9-4624-a5c4-836135b39d99 (view SPL)CEFPROZIL TABLETS USP10771078Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-02-135000931077, 000931078
86133611e-19c1-4df2-8c23-8573aaf63020 (view SPL)prescriptionHuman PrescriptionNorthstar Rx LlcANALYSIS, API MANUFACTURE, MANUFACTURE2013-01-051167140398, 167140399
975d57e35-ffeb-4d88-8dba-5458e284fd82 (view SPL)CEFPROZIL TABLETS USP 250 mg and 500 mgRx onlyprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-05-071548685756
10a547cc0a-6af0-49c7-a5ea-c41684cc36ae (view SPL)CEFPROZIL TABLETS, USP 250 mg and 500 mg CEFPROZIL for ORAL SUSPENSION, USP 125 mg/5 mL and 250 mg/5 mLprescriptionHuman PrescriptionSandoz Inc2015-05-1511007815043, 007815044, 007816202, 007816203cefprozil Oral Suspension
11af24a86f-8072-49a6-94ec-2f17fe81812b (view SPL)prescriptionHuman PrescriptionCitron Pharma Llc2013-12-031572370036, 572370037
12b9111a81-07c4-4458-b994-a4ad504986d8 (view SPL)prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2013-08-125658620068, 658620069
13d2dbfc48-063b-41c0-864c-2c9426ba89c1 (view SPL)CEFPROZIL TABLETS, USP 250 mg and 500 mg CEFPROZIL for ORAL SUSPENSION, USP 125 mg/5 mL and 250 mg/5 mLprescriptionHuman PrescriptionDava Pharmaceuticals, Inc.2014-03-0610672530231, 672530232, 672530233, 672530234cefprozil Oral Suspension
14f85f23ef-a73f-47f7-8283-8dab1afdc792 (view SPL)Cefprozil Tablets USP, 250 mg and 500 mgprescriptionHuman PrescriptionWockhardt Usa Llc.ANALYSIS, LABEL, MANUFACTURE, PACK2012-08-211646790712

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