Cefaclor Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
West-Ward Pharmaceutical Corp (2015-07-27)
Oldest Current Product
1995-04-05
License(s)
ANDA
RxNORM
ORAL CAPSULE\CEFACLOR
FDAOB
ORAL\CAPSULE\CEFACLOR
SPL Active
ORAL\CAPSULE\CEFACLOR
SPL Moiety
ORAL\CAPSULE\CEFACLOR
ORAL\CAPSULE\CEFACLOR ANHYDROUS
ORAL\CAPSULE\CEFACLOR: CEFACLOR ANHYDROUS

product(s) by strength(s)

cefaclor 250 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439985ANDAWest-Ward Pharmaceutical Corp2007-05-01CEFACLORORALCAPSULEANDA06535095990c4e-f5b1-4fad-be77-106166a71423
2477810266ANDAAlvogen, Inc.2010-01-18CEFACLORORALCAPSULEANDA065146447da05c-c90f-40eb-a8d9-3e8c69e19c00
3614420171ANDACarlsbad Technology, Inc.2008-07-31CEFACLORORALCAPSULEANDA0651462f61354e-bcb0-41aa-955f-51eabc11387b

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548683478ANDAPhysicians Total Care, Inc.1996-01-24CEFACLORORALCAPSULE633040658ANDA064156fe8b7729-d870-4e61-a5a4-91e28bdd5a94
2636291305ANDABryant Ranch Prepack2009-11-06CEFACLORORALCAPSULEANDA064156a61b7e77-ed45-42dd-a97f-b12a0dcca8da

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1545693901ANDAA-S Medication Solutions Llc2007-05-01CEFACLORORALCAPSULE001439985ANDA06535046fc6bb9-a638-46e9-9328-796f5ebf968a
2636291320ANDABryant Ranch Prepack2007-05-01CEFACLORORALCAPSULE001439985ANDA065350983638ac-f2ef-4dce-b452-a6691ce3fb7d

cefaclor 500 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439986ANDAWest-Ward Pharmaceutical Corp2007-05-01CEFACLORORALCAPSULEANDA06535095990c4e-f5b1-4fad-be77-106166a71423
2477810267ANDAAlvogen, Inc.2010-01-18CEFACLORORALCAPSULEANDA065146447da05c-c90f-40eb-a8d9-3e8c69e19c00
3614420172ANDACarlsbad Technology, Inc.2008-07-31CEFACLORORALCAPSULEANDA0651462f61354e-bcb0-41aa-955f-51eabc11387b

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548683511ANDAPhysicians Total Care, Inc.1995-04-05CEFACLORORALCAPSULE633040659ANDA064156fe8b7729-d870-4e61-a5a4-91e28bdd5a94

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1430630194ANDAPd-Rx Pharmaceuticals, Inc.2007-05-01CEFACLORORALCAPSULE001439986ANDA065350b093ec49-da83-40e3-8e1c-8a64b7f45d27
2545693902ANDAA-S Medication Solutions Llc2007-05-01CEFACLORORALCAPSULE001439986ANDA06535046fc6bb9-a638-46e9-9328-796f5ebf968a

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA062205CEFACLORTrueCEPH INTERNATIONAL CORPANDA062205_001, ANDA062205_002
2ANDA064061CEFACLORTrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1995-04-27ANDA064061_001, ANDA064061_002
3ANDA064081CEFACLORTrueTEVA PHARMACEUTICALS USA INC1996-09-16ANDA064081_001, ANDA064081_002
4ANDA064107CEFACLORTrueDAVA PHARMACEUTICALS INC1995-04-27ANDA064107_001, ANDA064107_002
5ANDA064145CEFACLORTrueTEVA PHARMACEUTICALS USA INC1996-06-24ANDA064145_001, ANDA064145_002
6ANDA064148CEFACLORTrueWATSON LABORATORIES INC1996-05-23ANDA064148_001, ANDA064148_002
7ANDA064156CEFACLORTrueRANBAXY PHARMACEUTICALS INC1997-08-28ANDA064156_001, ANDA064156_002
8ANDA065146CEFACLORYUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD2004-01-22ANDA065146_001, ANDA065146_002
9ANDA065350CEFACLORHIKMA PHARMACEUTICALS2007-04-03ANDA065350_001, ANDA065350_002
10NDA050521CECLORTrueELI LILLY AND CONDA050521_001, NDA050521_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA062205_001discontinuedCEFACLOR (EQ 250MG BASE)ORALCAPSULEFalseCEFACLOR
2ANDA062205_002discontinuedCEFACLOR (EQ 500MG BASE)ORALCAPSULEFalseCEFACLOR
3ANDA064061_001discontinuedCEFACLOR (EQ 250MG BASE)ORALCAPSULEFalse1995-04-27CEFACLOR
4ANDA064061_002discontinuedCEFACLOR (EQ 500MG BASE)ORALCAPSULEFalse1995-04-27CEFACLOR
5ANDA064081_001discontinuedCEFACLOR (EQ 250MG BASE)ORALCAPSULEFalse1996-09-16CEFACLOR
6ANDA064081_002discontinuedCEFACLOR (EQ 500MG BASE)ORALCAPSULEFalse1996-09-16CEFACLOR
7ANDA064107_001discontinuedCEFACLOR (EQ 250MG BASE)ORALCAPSULEFalse1995-04-27CEFACLOR
8ANDA064107_002discontinuedCEFACLOR (EQ 500MG BASE)ORALCAPSULEFalse1995-04-27CEFACLOR
9ANDA064145_001discontinuedCEFACLOR (EQ 250MG BASE)ORALCAPSULEFalse1996-06-24CEFACLOR
10ANDA064145_002discontinuedCEFACLOR (EQ 500MG BASE)ORALCAPSULEFalse1996-06-24CEFACLOR
11ANDA064148_001discontinuedCEFACLOR (EQ 250MG BASE)ORALCAPSULEFalse1996-05-23CEFACLOR
12ANDA064148_002discontinuedCEFACLOR (EQ 500MG BASE)ORALCAPSULEFalse1996-05-23CEFACLOR
13ANDA064156_001discontinuedCEFACLOR (EQ 250MG BASE)ORALCAPSULEFalse1997-08-28CEFACLOR
14ANDA064156_002discontinuedCEFACLOR (EQ 500MG BASE)ORALCAPSULEFalse1997-08-28CEFACLOR
15ANDA065146_001RXCEFACLOR (EQ 250MG BASE)ORALCAPSULEFalseAB2004-01-22CEFACLOR
16ANDA065146_002RXCEFACLOR (EQ 500MG BASE)ORALCAPSULEFalseAB2004-01-22CEFACLOR
17ANDA065350_001RXCEFACLOR (EQ 250MG BASE)ORALCAPSULEFalseAB2007-04-03CEFACLOR
18ANDA065350_002RXCEFACLOR (EQ 500MG BASE)ORALCAPSULETrueAB2007-04-03CEFACLOR
19NDA050521_001discontinuedCEFACLOR (EQ 250MG BASE)ORALCAPSULEFalseCECLOR
20NDA050521_002discontinuedCEFACLOR (EQ 500MG BASE)ORALCAPSULEFalseCECLOR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12f61354e-bcb0-41aa-955f-51eabc11387b (view SPL)Cefaclor Capsules USPprescriptionHuman PrescriptionCarlsbad Technology, Inc.LABEL, MANUFACTURE, PACK2012-06-291614420171, 614420172
2447da05c-c90f-40eb-a8d9-3e8c69e19c00 (view SPL)Cefaclor Capsules USPprescriptionHuman PrescriptionAlvogen, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2011-03-303477810266, 477810267
346fc6bb9-a638-46e9-9328-796f5ebf968a (view SPL)CEFACLOR CAPSULES, USP Rx onlyprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-06-201545693901, 545693902
495990c4e-f5b1-4fad-be77-106166a71423 (view SPL)CEFACLOR CAPSULES, USPRev. 07/15Rx OnlyprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpMANUFACTURE2015-07-2711001439985, 001439986
5983638ac-f2ef-4dce-b452-a6691ce3fb7d (view SPL)CEFACLOR CAPSULES, USP Rx onlyprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-181000636291320
6a61b7e77-ed45-42dd-a97f-b12a0dcca8da (view SPL)CEFACLOR 250mg CapsuleprescriptionHuman PrescriptionBryant Ranch Prepackrepack2009-11-061001636291305
7b093ec49-da83-40e3-8e1c-8a64b7f45d27 (view SPL)CEFACLOR CAPSULES, USPRx onlyprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2009-09-282430630194
8fe8b7729-d870-4e61-a5a4-91e28bdd5a94 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-12-081548683478, 548683511

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