cefprozil Oral Suspension

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Lupin Pharmaceuticals, Inc. (2011-04-01)
Oldest Current Product
2005-12-01
License(s)
ANDA
RxNORM
ORAL SUSPENSION\CEFPROZIL
FDAOB
ORAL\FOR SUSPENSION\CEFPROZIL
SPL Active
ORAL\POWDER, FOR SUSPENSION\CEFPROZIL
SPL Moiety
ORAL\POWDER, FOR SUSPENSION\CEFPROZIL
ORAL\POWDER, FOR SUSPENSION\CEFPROZIL ANHYDROUS

product(s) by strength(s)

cefprozil 25 mg/ml oral suspension

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000931075ANDATeva Pharmaceuticals Usa Inc2006-03-04CEFPROZILORALPOWDER, FOR SUSPENSIONANDA0652366737ed97-9559-44c7-889b-6bc0e20eb36b
2007816202ANDASandoz Inc2005-12-05CEFPROZILORALPOWDER, FOR SUSPENSIONANDA065257a547cc0a-6af0-49c7-a5ea-c41684cc36ae
3167140396ANDANorthstar Rx Llc2007-01-30CEFPROZILORALPOWDER, FOR SUSPENSIONANDA0653818e3943b5-8c30-4c81-bcfa-aeaaa1d75fb4
4420430262ANDAOrchidpharma Inc2015-08-19CEFPROZILORALPOWDER, FOR SUSPENSIONANDA0652849825b787-72de-4555-9907-3738bd761e57
5572370034ANDACitron Pharma Llc2007-01-30CEFPROZILORALPOWDER, FOR SUSPENSIONANDA065381d7fac9cc-30e1-4762-a01b-04f1bd3b2a56
6658620099ANDAAurobindo Pharma Limited2007-01-30CEFPROZILORALPOWDER, FOR SUSPENSIONANDA06538197675251-70b8-43bc-93ea-f9ef6bb8cb68
7672530233ANDADava Pharmaceuticals, Inc.2014-08-01CEFPROZILORALPOWDER, FOR SUSPENSIONANDA065257d2dbfc48-063b-41c0-864c-2c9426ba89c1
8681800401ANDALupin Pharmaceuticals, Inc.2005-12-01CEFPROZILORALPOWDER, FOR SUSPENSIONANDA0652613ec55c0a-1456-412e-972f-352b3135c8f2

cefprozil 50 mg/ml oral suspension

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000931076ANDATeva Pharmaceuticals Usa Inc2005-12-23CEFPROZILORALPOWDER, FOR SUSPENSIONANDA0652366737ed97-9559-44c7-889b-6bc0e20eb36b
2007816203ANDASandoz Inc2005-12-05CEFPROZILORALPOWDER, FOR SUSPENSIONANDA065257a547cc0a-6af0-49c7-a5ea-c41684cc36ae
3167140397ANDANorthstar Rx Llc2007-01-30CEFPROZILORALPOWDER, FOR SUSPENSIONANDA0653818e3943b5-8c30-4c81-bcfa-aeaaa1d75fb4
4420430263ANDAOrchidpharma Inc2015-08-19CEFPROZILORALPOWDER, FOR SUSPENSIONANDA0652849825b787-72de-4555-9907-3738bd761e57
5572370035ANDACitron Pharma Llc2007-01-30CEFPROZILORALPOWDER, FOR SUSPENSIONANDA065381d7fac9cc-30e1-4762-a01b-04f1bd3b2a56
6658620100ANDAAurobindo Pharma Limited2007-01-30CEFPROZILORALPOWDER, FOR SUSPENSIONANDA06538197675251-70b8-43bc-93ea-f9ef6bb8cb68
7672530234ANDADava Pharmaceuticals, Inc.2014-08-01CEFPROZILORALPOWDER, FOR SUSPENSIONANDA065257d2dbfc48-063b-41c0-864c-2c9426ba89c1

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1545695785ANDAA-S Medication Solutions Llc2005-12-01CEFPROZILORALPOWDER, FOR SUSPENSION681800402ANDA0652614d17e35a-0ca1-4a6b-8b69-ea8f0d62938f
2548685757ANDAPhysicians Total Care, Inc.2007-02-05CEFPROZILORALPOWDER, FOR SUSPENSION68180040203ANDA065261c6d3c1ff-d873-4903-befa-c0ba47034c6e

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA065202CEFPROZILTrueRANBAXY LABORATORIES LTD2006-06-30ANDA065202_001, ANDA065202_002
2ANDA065236CEFPROZILTEVA PHARMACEUTICALS USA2005-12-08ANDA065236_001, ANDA065236_002
3ANDA065257CEFPROZILSANDOZ INC2005-12-08ANDA065257_001, ANDA065257_002
4ANDA065261CEFPROZILLUPIN LTD2005-12-19ANDA065261_001, ANDA065261_002
5ANDA065284CEFPROZILORCHID HEALTHCARE2005-12-30ANDA065284_001, ANDA065284_002
6ANDA065351CEFPROZILAPOTEX INC2012-02-29ANDA065351_001, ANDA065351_002
7ANDA065381CEFPROZILAUROBINDO PHARMA LTD2007-01-30ANDA065381_001, ANDA065381_002
8NDA050665CEFZILTrueCORDEN PHARMA LATINA SPA1991-12-23NDA050665_001, NDA050665_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA065202_001discontinuedCEFPROZIL (125MG/5ML)ORALFOR SUSPENSIONFalse2006-06-30CEFPROZIL
2ANDA065202_002discontinuedCEFPROZIL (250MG/5ML)ORALFOR SUSPENSIONFalse2006-06-30CEFPROZIL
3ANDA065236_001RXCEFPROZIL (125MG/5ML)ORALFOR SUSPENSIONFalseAB2005-12-08CEFPROZIL
4ANDA065236_002RXCEFPROZIL (250MG/5ML)ORALFOR SUSPENSIONFalseAB2005-12-08CEFPROZIL
5ANDA065257_001RXCEFPROZIL (125MG/5ML)ORALFOR SUSPENSIONFalseAB2005-12-08CEFPROZIL
6ANDA065257_002RXCEFPROZIL (250MG/5ML)ORALFOR SUSPENSIONFalseAB2005-12-08CEFPROZIL
7ANDA065261_001RXCEFPROZIL (125MG/5ML)ORALFOR SUSPENSIONFalseAB2005-12-19CEFPROZIL
8ANDA065261_002RXCEFPROZIL (250MG/5ML)ORALFOR SUSPENSIONTrueAB2005-12-19CEFPROZIL
9ANDA065284_001RXCEFPROZIL (250MG/5ML)ORALFOR SUSPENSIONFalseAB2005-12-30CEFPROZIL
10ANDA065284_002RXCEFPROZIL (125MG/5ML)ORALFOR SUSPENSIONFalseAB2005-12-30CEFPROZIL
11ANDA065351_001RXCEFPROZIL (125MG/5ML)ORALFOR SUSPENSIONFalseAB2012-02-29CEFPROZIL
12ANDA065351_002RXCEFPROZIL (250MG/5ML)ORALFOR SUSPENSIONFalseAB2012-02-29CEFPROZIL
13ANDA065381_001RXCEFPROZIL (125MG/5ML)ORALFOR SUSPENSIONFalseAB2007-01-30CEFPROZIL
14ANDA065381_002RXCEFPROZIL (250MG/5ML)ORALFOR SUSPENSIONFalseAB2007-01-30CEFPROZIL
15NDA050665_001discontinuedCEFPROZIL (125MG/5ML)ORALFOR SUSPENSIONFalse1991-12-23CEFZIL
16NDA050665_002discontinuedCEFPROZIL (250MG/5ML)ORALFOR SUSPENSIONFalse1991-12-23CEFZIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
13ec55c0a-1456-412e-972f-352b3135c8f2 (view SPL)cefprozil for oral suspension usp 125 mg/5 mL and 250 mg/5 mLprescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.2011-04-012681800401
24d17e35a-0ca1-4a6b-8b69-ea8f0d62938f (view SPL)cefprozil for oral suspension usp 125 mg/5 mL and 250 mg/5 mLprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-221545695785
36737ed97-9559-44c7-889b-6bc0e20eb36b (view SPL)CEFPROZIL FOR ORAL SUSPENSION USP10751076Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2012-08-134000931075, 000931076
48e3943b5-8c30-4c81-bcfa-aeaaa1d75fb4 (view SPL)prescriptionHuman PrescriptionNorthstar Rx LlcANALYSIS, API MANUFACTURE, MANUFACTURE2013-01-091167140396, 167140397
597675251-70b8-43bc-93ea-f9ef6bb8cb68 (view SPL)prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2013-07-056658620099, 658620100
69825b787-72de-4555-9907-3738bd761e57 (view SPL)CEFPROZIL FOR ORAL SUSPENSION, USPprescriptionHuman PrescriptionOrchidpharma Incanalysis, label, manufacture, pack2015-08-241420430262, 420430263
7a547cc0a-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 Inc2015-05-1511007816202, 007816203, 007815043, 007815044cefprozil Oral Tablet
8c6d3c1ff-d873-4903-befa-c0ba47034c6e (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-12-081548685757
9d2dbfc48-063b-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.2014-03-0610672530233, 672530234, 672530231, 672530232cefprozil Oral Tablet
10d7fac9cc-30e1-4762-a01b-04f1bd3b2a56 (view SPL)Cefprozil for Oral Suspension, USP Rx onlyprescriptionHuman PrescriptionCitron Pharma Llc2013-12-191572370034, 572370035

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