Cefaclor Oral Suspension

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Fsc Laboratories, Inc (2015-10-27)
Oldest Current Product
1997-10-02
License(s)
ANDA
RxNORM
ORAL SUSPENSION\CEFACLOR
FDAOB
ORAL\FOR SUSPENSION\CEFACLOR
SPL Active
ORAL\FOR SUSPENSION\CEFACLOR
ORAL\SUSPENSION\CEFACLOR
SPL Moiety
ORAL\FOR SUSPENSION\CEFACLOR ANHYDROUS
ORAL\SUSPENSION\CEFACLOR
ORAL\SUSPENSION\CEFACLOR ANHYDROUS

product(s) by strength(s)

cefaclor 25 mg/ml oral suspension

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1135510125ANDAFsc Laboratories, Inc2015-10-26CEFACLORORALFOR SUSPENSIONANDA065412a619cf07-deb9-474d-bdb9-f662909540d4
2165710070ANDAPack Pharmaceuticals Llc2012-10-25CEFACLORORALSUSPENSIONANDA065412ac5e34a9-994b-4611-aa41-3d1ed58a91c0
3614420173ANDACarlsbad Technology, Inc.2012-03-27CEFACLORORALSUSPENSIONANDA0654129f919252-7a87-4386-a64c-5d8213f7e881

cefaclor 37.4 mg/ml oral suspension

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1614420174ANDACarlsbad Technology, Inc.2012-03-27CEFACLORORALSUSPENSIONANDA0654129f919252-7a87-4386-a64c-5d8213f7e881

cefaclor 50 mg/ml oral suspension

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1135510250ANDAFsc Laboratories, Inc2015-10-26CEFACLORORALFOR SUSPENSIONANDA065412a619cf07-deb9-474d-bdb9-f662909540d4
2165710071ANDAPack Pharmaceuticals Llc2012-10-31CEFACLORORALSUSPENSIONANDA065412ac5e34a9-994b-4611-aa41-3d1ed58a91c0
3614420175ANDACarlsbad Technology, Inc.2012-03-27CEFACLORORALSUSPENSIONANDA0654129f919252-7a87-4386-a64c-5d8213f7e881

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950782ANDARebel Distributors Corp1997-10-02CEFACLORORALSUSPENSION633040956ANDA0641649e8890f0-e04a-4555-ac8d-d1b792a5c276

cefaclor 75 mg/ml oral suspension

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1135510375ANDAFsc Laboratories, Inc2015-10-26CEFACLORORALFOR SUSPENSIONANDA065412a619cf07-deb9-474d-bdb9-f662909540d4
2165710072ANDAPack Pharmaceuticals Llc2012-10-31CEFACLORORALSUSPENSIONANDA065412ac5e34a9-994b-4611-aa41-3d1ed58a91c0
3614420176ANDACarlsbad Technology, Inc.2012-03-27CEFACLORORALSUSPENSIONANDA0654129f919252-7a87-4386-a64c-5d8213f7e881

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA062206CEFACLORTrueFACTA FARMACEUTICI SPAANDA062206_001, ANDA062206_002, ANDA062206_003, ANDA062206_004
2ANDA064070CEFACLORTrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1995-04-28ANDA064070_001
3ANDA064085CEFACLORTrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1995-04-28ANDA064085_001
4ANDA064086CEFACLORTrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1995-04-28ANDA064086_001
5ANDA064087CEFACLORTrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1995-04-28ANDA064087_001
6ANDA064110CEFACLORTrueDAVA PHARMACEUTICALS INC1995-04-28ANDA064110_001
7ANDA064114CEFACLORTrueDAVA PHARMACEUTICALS INC1995-04-28ANDA064114_001
8ANDA064115CEFACLORTrueDAVA PHARMACEUTICALS INC1995-04-28ANDA064115_001
9ANDA064116CEFACLORTrueDAVA PHARMACEUTICALS INC1995-04-28ANDA064116_001
10ANDA064155CEFACLORTrueRANBAXY PHARMACEUTICALS INC1997-10-02ANDA064155_001
11ANDA064164CEFACLORTrueRANBAXY PHARMACEUTICALS INC1997-10-02ANDA064164_001
12ANDA064165CEFACLORTrueRANBAXY PHARMACEUTICALS INC1997-10-02ANDA064165_001
13ANDA064166CEFACLORTrueRANBAXY PHARMACEUTICALS INC1997-10-02ANDA064166_001
14ANDA064204CEFACLORTrueWATSON LABORATORIES INC1998-02-18ANDA064204_001
15ANDA064205CEFACLORTrueWATSON LABORATORIES INC1998-02-18ANDA064205_001
16ANDA064206CEFACLORTrueWATSON LABORATORIES INC1998-02-18ANDA064206_001
17ANDA064207CEFACLORTrueWATSON LABORATORIES INC1998-02-18ANDA064207_001
18ANDA065412CEFACLORYUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD2012-02-17ANDA065412_001, ANDA065412_002, ANDA065412_003, ANDA065412_004
19NDA050522CECLORTrueELI LILLY AND CONDA050522_001, NDA050522_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA062206_001discontinuedCEFACLOR (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalseCEFACLOR
2ANDA062206_002discontinuedCEFACLOR (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalseCEFACLOR
3ANDA062206_003discontinuedCEFACLOR (EQ 187MG BASE/5ML)ORALFOR SUSPENSIONFalse1988-04-20CEFACLOR
4ANDA062206_004discontinuedCEFACLOR (EQ 375MG BASE/5ML)ORALFOR SUSPENSIONFalse1988-04-20CEFACLOR
5ANDA064070_001discontinuedCEFACLOR (EQ 375MG BASE/5ML)ORALFOR SUSPENSIONFalse1995-04-28CEFACLOR
6ANDA064085_001discontinuedCEFACLOR (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalse1995-04-28CEFACLOR
7ANDA064086_001discontinuedCEFACLOR (EQ 187MG BASE/5ML)ORALFOR SUSPENSIONFalse1995-04-28CEFACLOR
8ANDA064087_001discontinuedCEFACLOR (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalse1995-04-28CEFACLOR
9ANDA064110_001discontinuedCEFACLOR (EQ 375MG BASE/5ML)ORALFOR SUSPENSIONFalse1995-04-28CEFACLOR
10ANDA064114_001discontinuedCEFACLOR (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalse1995-04-28CEFACLOR
11ANDA064115_001discontinuedCEFACLOR (EQ 187MG BASE/5ML)ORALFOR SUSPENSIONFalse1995-04-28CEFACLOR
12ANDA064116_001discontinuedCEFACLOR (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalse1995-04-28CEFACLOR
13ANDA064155_001discontinuedCEFACLOR (EQ 375MG BASE/5ML)ORALFOR SUSPENSIONFalse1997-10-02CEFACLOR
14ANDA064164_001discontinuedCEFACLOR (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalse1997-10-02CEFACLOR
15ANDA064165_001discontinuedCEFACLOR (EQ 187MG BASE/5ML)ORALFOR SUSPENSIONFalse1997-10-02CEFACLOR
16ANDA064166_001discontinuedCEFACLOR (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalse1997-10-02CEFACLOR
17ANDA064204_001discontinuedCEFACLOR (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalse1998-02-18CEFACLOR
18ANDA064205_001discontinuedCEFACLOR (EQ 187MG BASE/5ML)ORALFOR SUSPENSIONFalse1998-02-18CEFACLOR
19ANDA064206_001discontinuedCEFACLOR (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalse1998-02-18CEFACLOR
20ANDA064207_001discontinuedCEFACLOR (EQ 375MG BASE/5ML)ORALFOR SUSPENSIONFalse1998-02-18CEFACLOR
21ANDA065412_001RXCEFACLOR (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2012-02-17CEFACLOR
22ANDA065412_002RXCEFACLOR (EQ 187MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2012-02-17CEFACLOR
23ANDA065412_003RXCEFACLOR (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2012-02-17CEFACLOR
24ANDA065412_004RXCEFACLOR (EQ 375MG BASE/5ML)ORALFOR SUSPENSIONTrueAB2012-02-17CEFACLOR
25NDA050522_001discontinuedCEFACLOR (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalseCECLOR
26NDA050522_002discontinuedCEFACLOR (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalseCECLOR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
19e8890f0-e04a-4555-ac8d-d1b792a5c276 (view SPL)CEFACLOR CAPSULES USP AND CEFACLOR FOR ORAL SUSPENSION USPRx onlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-07-201216950782
29f919252-7a87-4386-a64c-5d8213f7e881 (view SPL)Cefaclor for Oral Suspension, USPprescriptionHuman PrescriptionCarlsbad Technology, Inc.LABEL, MANUFACTURE, PACK2015-09-093614420173, 614420174, 614420175, 614420176
3a619cf07-deb9-474d-bdb9-f662909540d4 (view SPL)Cefaclor for Oral Suspension, USPprescriptionHuman PrescriptionFsc Laboratories, Inc2015-10-271135510125, 135510250, 135510375
4ac5e34a9-994b-4611-aa41-3d1ed58a91c0 (view SPL)Cefaclor for Oral Suspension, USPprescriptionHuman PrescriptionPack Pharmaceuticals LlcMANUFACTURE2012-10-252165710070, 165710071, 165710072

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