Cephalexin Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2015-07-20)
Oldest Current Product
1990-09-30
License(s)
ANDA
RxNORM
ORAL TABLET\CEPHALEXIN
FDAOB
ORAL\CAPSULE\CEPHALEXIN
ORAL\TABLET\CEPHALEXIN
SPL Active
ORAL\TABLET\CEPHALEXIN
SPL Moiety
ORAL\TABLET\CEPHALEXIN ANHYDROUS

product(s) by strength(s)

cephalexin 250 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000932238ANDATeva Pharmaceuticals Usa Inc1990-09-30CEPHALEXINORALTABLETANDA06302319307ff0-71de-477b-965d-ea243e5ede3a

cephalexin 500 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000932240ANDATeva Pharmaceuticals Usa Inc1990-09-30CEPHALEXINORALTABLETANDA06302419307ff0-71de-477b-965d-ea243e5ede3a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1516550026ANDANorthwind Pharmaceuticals, Llc2014-07-18CEPHALEXINORALTABLET658620019ANDA06525341c59e38-37bd-4f3a-8b06-6be03012f537

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA061969CEPHALEXINTrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USAANDA061969_001, ANDA061969_002Cephalexin Oral Capsule
2ANDA062118CEPHALEXINTrueFACTA FARMACEUTICI SPAANDA062118_001, ANDA062118_002Cephalexin Oral Capsule
3ANDA062702CEPHALEXINTEVA PHARMACEUTICALS USA INC1987-02-13ANDA062702_001, ANDA062702_002Cephalexin Oral Capsule
4ANDA062713CEPHALEXINBELCHER PHARMACEUTICALS LLC1988-07-15ANDA062713_001, ANDA062713_002Cephalexin Oral Capsule
5ANDA062745KEFLETTrueELI LILLY AND CO1986-12-01ANDA062745_001, ANDA062745_002
6ANDA062760CEPHALEXINTrueTEVA PHARMACEUTICALS USA INC1987-04-24ANDA062760_001Cephalexin Oral Capsule
7ANDA062761CEPHALEXINTrueTEVA PHARMACEUTICALS USA INC1987-04-24ANDA062761_001Cephalexin Oral Capsule
8ANDA062773CEPHALEXINTrueBARR LABORATORIES INC1987-06-26ANDA062773_001Cephalexin Oral Capsule
9ANDA062775CEPHALEXINTrueBARR LABORATORIES INC1987-04-22ANDA062775_001Cephalexin Oral Capsule
10ANDA062791CEPHALEXINSUN PHARMACEUTICAL INDUSTRIES LTD1987-06-11ANDA062791_001, ANDA062791_002Cephalexin Oral Capsule
11ANDA062809CEPHALEXINTruePUREPAC PHARMACEUTICAL CO1987-04-22ANDA062809_001, ANDA062809_002Cephalexin Oral Capsule
12ANDA062821CEPHALEXINTrueTEVA PHARMACEUTICALS USA INC1988-02-05ANDA062821_001Cephalexin Oral Capsule
13ANDA062823CEPHALEXINTrueTEVA PHARMACEUTICALS USA INC1988-02-05ANDA062823_001Cephalexin Oral Capsule
14ANDA062826CEPHALEXINTrueBARR LABORATORIES INC1987-08-17ANDA062826_001
15ANDA062827CEPHALEXINTrueBARR LABORATORIES INC1987-08-17ANDA062827_001
16ANDA062863CEPHALEXINTrueVITARINE PHARMACEUTICALS INC1988-08-11ANDA062863_001, ANDA062863_002, ANDA062863_003
17ANDA062869CEPHALEXINTrueJEROME STEVENS PHARMACEUTICALS INC1988-03-17ANDA062869_001Cephalexin Oral Capsule
18ANDA062870CEPHALEXINTrueJEROME STEVENS PHARMACEUTICALS INC1988-03-17ANDA062870_001Cephalexin Oral Capsule
19ANDA062871CEPHALEXINTrueYOSHITOMI PHARMACEUTICAL INDUSTRIES LTD1988-07-05ANDA062871_001Cephalexin Oral Capsule
20ANDA062872CEPHALEXINTrueYOSHITOMI PHARMACEUTICAL INDUSTRIES LTD1988-06-20ANDA062872_001Cephalexin Oral Capsule
21ANDA062973CEPHALEXINTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBB1988-11-08ANDA062973_001Cephalexin Oral Capsule
22ANDA062974CEPHALEXINTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBB1988-11-23ANDA062974_001Cephalexin Oral Capsule
23ANDA063023CEPHALEXINTEVA PHARMACEUTICALS USA INC1989-01-12ANDA063023_001
24ANDA063024CEPHALEXINTEVA PHARMACEUTICALS USA INC1989-01-12ANDA063024_001
25ANDA063063CEPHALEXINTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBB1989-09-29ANDA063063_001, ANDA063063_002Cephalexin Oral Capsule
26ANDA063186CEPHALEXINTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBB1994-12-30ANDA063186_001, ANDA063186_002Cephalexin Oral Capsule
27ANDA065007CEPHALEXINSUN PHARMACEUTICAL INDUSTRIES LTD1999-09-16ANDA065007_001, ANDA065007_002Cephalexin Oral Capsule
28ANDA065152CEPHALEXINYUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD2005-02-24ANDA065152_001, ANDA065152_002Cephalexin Oral Capsule
29ANDA065215CEPHALEXINHIKMA PHARMACEUTICALS2006-01-24ANDA065215_001, ANDA065215_002Cephalexin Oral Capsule
30ANDA065229CEPHALEXINLUPIN LTD2005-11-25ANDA065229_001, ANDA065229_002Cephalexin Oral Capsule
31ANDA065248CEPHALEXINORCHID HEALTHCARE2005-06-28ANDA065248_001, ANDA065248_002Cephalexin Oral Capsule
32ANDA065253CEPHALEXINAUROBINDO PHARMA LTD INC2005-11-16ANDA065253_001, ANDA065253_002Cephalexin Oral Capsule
33ANDA090836CEPHALEXINALKEM LABORATORIES LTD2010-12-20ANDA090836_001, ANDA090836_002, ANDA090836_003, ANDA090836_004Cephalexin Oral Capsule
34NDA050405KEFLEXSHIONOGI INCNDA050405_002, NDA050405_003, NDA050405_004, NDA050405_005Cephalexin Oral Capsule
35NDA050440KEFLETTrueELI LILLY AND CONDA050440_001, NDA050440_002, NDA050440_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA061969_001discontinuedCEPHALEXIN (EQ 250MG BASE)ORALCAPSULEFalseCEPHALEXIN
2ANDA061969_002discontinuedCEPHALEXIN (EQ 500MG BASE)ORALCAPSULEFalseCEPHALEXIN
3ANDA062118_001discontinuedCEPHALEXIN (EQ 250MG BASE)ORALCAPSULEFalseCEPHALEXIN
4ANDA062118_002discontinuedCEPHALEXIN (EQ 500MG BASE)ORALCAPSULEFalseCEPHALEXIN
5ANDA062702_001RXCEPHALEXIN (EQ 250MG BASE)ORALCAPSULEFalseAB1987-02-13CEPHALEXIN
6ANDA062702_002RXCEPHALEXIN (EQ 500MG BASE)ORALCAPSULEFalseAB1987-02-13CEPHALEXIN
7ANDA062713_001RXCEPHALEXIN (EQ 250MG BASE)ORALCAPSULEFalseAB1988-07-15CEPHALEXIN
8ANDA062713_002RXCEPHALEXIN (EQ 500MG BASE)ORALCAPSULEFalseAB1988-07-15CEPHALEXIN
9ANDA062745_001discontinuedCEPHALEXIN (EQ 250MG BASE)ORALTABLETFalse1986-12-01KEFLET
10ANDA062745_002discontinuedCEPHALEXIN (EQ 500MG BASE)ORALTABLETFalse1986-12-01KEFLET
11ANDA062760_001discontinuedCEPHALEXIN (EQ 250MG BASE)ORALCAPSULEFalse1987-04-24CEPHALEXIN
12ANDA062761_001discontinuedCEPHALEXIN (EQ 500MG BASE)ORALCAPSULEFalse1987-04-24CEPHALEXIN
13ANDA062773_001discontinuedCEPHALEXIN (EQ 250MG BASE)ORALCAPSULEFalse1987-06-26CEPHALEXIN
14ANDA062775_001discontinuedCEPHALEXIN (EQ 500MG BASE)ORALCAPSULEFalse1987-04-22CEPHALEXIN
15ANDA062791_001RXCEPHALEXIN (EQ 250MG BASE)ORALCAPSULEFalseAB1987-06-11CEPHALEXIN
16ANDA062791_002RXCEPHALEXIN (EQ 500MG BASE)ORALCAPSULEFalseAB1987-06-11CEPHALEXIN
17ANDA062809_001discontinuedCEPHALEXIN (EQ 250MG BASE)ORALCAPSULEFalse1987-04-22CEPHALEXIN
18ANDA062809_002discontinuedCEPHALEXIN (EQ 500MG BASE)ORALCAPSULEFalse1987-04-22CEPHALEXIN
19ANDA062821_001discontinuedCEPHALEXIN (EQ 250MG BASE)ORALCAPSULEFalse1988-02-05CEPHALEXIN
20ANDA062823_001discontinuedCEPHALEXIN (EQ 500MG BASE)ORALCAPSULEFalse1988-02-05CEPHALEXIN
21ANDA062826_001discontinuedCEPHALEXIN (EQ 250MG BASE)ORALTABLETFalse1987-08-17CEPHALEXIN
22ANDA062827_001discontinuedCEPHALEXIN (EQ 500MG BASE)ORALTABLETFalse1987-08-17CEPHALEXIN
23ANDA062863_001discontinuedCEPHALEXIN (EQ 250MG BASE)ORALTABLETFalse1988-08-11CEPHALEXIN
24ANDA062863_002discontinuedCEPHALEXIN (EQ 500MG BASE)ORALTABLETFalse1988-08-11CEPHALEXIN
25ANDA062863_003discontinuedCEPHALEXIN (EQ 1GM BASE)ORALTABLETFalse1988-08-11CEPHALEXIN
26ANDA062869_001discontinuedCEPHALEXIN (EQ 500MG BASE)ORALCAPSULEFalse1988-03-17CEPHALEXIN
27ANDA062870_001discontinuedCEPHALEXIN (EQ 250MG BASE)ORALCAPSULEFalse1988-03-17CEPHALEXIN
28ANDA062871_001discontinuedCEPHALEXIN (EQ 500MG BASE)ORALCAPSULEFalse1988-07-05CEPHALEXIN
29ANDA062872_001discontinuedCEPHALEXIN (EQ 250MG BASE)ORALCAPSULEFalse1988-06-20CEPHALEXIN
30ANDA062973_001discontinuedCEPHALEXIN (EQ 250MG BASE)ORALCAPSULEFalse1988-11-08CEPHALEXIN
31ANDA062974_001discontinuedCEPHALEXIN (EQ 500MG BASE)ORALCAPSULEFalse1988-11-23CEPHALEXIN
32ANDA063023_001RXCEPHALEXIN (EQ 250MG BASE)ORALTABLETFalse1989-01-12CEPHALEXIN
33ANDA063024_001RXCEPHALEXIN (EQ 500MG BASE)ORALTABLETTrue1989-01-12CEPHALEXIN
34ANDA063063_001discontinuedCEPHALEXIN (EQ 250MG BASE)ORALCAPSULEFalse1989-09-29CEPHALEXIN
35ANDA063063_002discontinuedCEPHALEXIN (EQ 500MG BASE)ORALCAPSULEFalse1989-09-29CEPHALEXIN
36ANDA063186_001discontinuedCEPHALEXIN (EQ 250MG BASE)ORALCAPSULEFalse1994-12-30CEPHALEXIN
37ANDA063186_002discontinuedCEPHALEXIN (EQ 500MG BASE)ORALCAPSULEFalse1994-12-30CEPHALEXIN
38ANDA065007_001RXCEPHALEXIN (EQ 250MG BASE)ORALCAPSULEFalseAB1999-09-16CEPHALEXIN
39ANDA065007_002RXCEPHALEXIN (EQ 500MG BASE)ORALCAPSULEFalseAB1999-09-16CEPHALEXIN
40ANDA065152_001RXCEPHALEXIN (EQ 250MG BASE)ORALCAPSULEFalseAB2005-02-24CEPHALEXIN
41ANDA065152_002RXCEPHALEXIN (EQ 500MG BASE)ORALCAPSULEFalseAB2005-02-24CEPHALEXIN
42ANDA065215_001RXCEPHALEXIN (EQ 250MG BASE)ORALCAPSULEFalseAB2006-01-24CEPHALEXIN
43ANDA065215_002RXCEPHALEXIN (EQ 500MG BASE)ORALCAPSULEFalseAB2006-01-24CEPHALEXIN
44ANDA065229_001RXCEPHALEXIN (EQ 250MG BASE)ORALCAPSULEFalseAB2005-11-25CEPHALEXIN
45ANDA065229_002RXCEPHALEXIN (EQ 500MG BASE)ORALCAPSULEFalseAB2005-11-25CEPHALEXIN
46ANDA065248_001RXCEPHALEXIN (EQ 250MG BASE)ORALCAPSULEFalseAB2005-06-28CEPHALEXIN
47ANDA065248_002RXCEPHALEXIN (EQ 500MG BASE)ORALCAPSULEFalseAB2005-06-28CEPHALEXIN
48ANDA065253_001RXCEPHALEXIN (EQ 250MG BASE)ORALCAPSULEFalseAB2005-11-16CEPHALEXIN
49ANDA065253_002RXCEPHALEXIN (EQ 500MG BASE)ORALCAPSULEFalseAB2005-11-16CEPHALEXIN
50ANDA090836_001RXCEPHALEXIN (EQ 250MG BASE)ORALCAPSULEFalseAB2010-12-20CEPHALEXIN
51ANDA090836_002RXCEPHALEXIN (EQ 500MG BASE)ORALCAPSULEFalseAB2010-12-20CEPHALEXIN
52ANDA090836_003RXCEPHALEXIN (EQ 333MG BASE)ORALCAPSULEFalse2013-03-29CEPHALEXIN
53ANDA090836_004RXCEPHALEXIN (EQ 750MG BASE)ORALCAPSULEFalseAB2013-03-29CEPHALEXIN
54NDA050405_002RXCEPHALEXIN (EQ 250MG BASE)ORALCAPSULEFalseABKEFLEX
55NDA050405_003RXCEPHALEXIN (EQ 500MG BASE)ORALCAPSULEFalseABKEFLEX
56NDA050405_004discontinuedCEPHALEXIN (EQ 333MG BASE)ORALCAPSULEFalse2006-05-12KEFLEX
57NDA050405_005RXCEPHALEXIN (EQ 750MG BASE)ORALCAPSULETrueAB2006-05-12KEFLEX
58NDA050440_001discontinuedCEPHALEXIN (EQ 500MG BASE)ORALTABLETFalseKEFLET
59NDA050440_002discontinuedCEPHALEXIN (EQ 1GM BASE)ORALTABLETFalseKEFLET
60NDA050440_003discontinuedCEPHALEXIN (EQ 250MG BASE)ORALTABLETFalse1987-02-26KEFLET

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
119307ff0-71de-477b-965d-ea243e5ede3a (view SPL)CEPHALEXIN CAPSULES USP, 250 mg and 500 mg / CEPHALEXIN FOR ORAL SUSPENSION USP, 125 mg/5 mL and 250 mg/5 mL / CEPHALEXIN TABLETS USP, 250 mg and 500 mg314531474175417722382240Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-07-2013000932238, 000932240, 000933145, 000933147, 000934175, 000934177Cephalexin Oral Suspension
Cephalexin Oral Capsule
241c59e38-37bd-4f3a-8b06-6be03012f537 (view SPL)Cephalexin 500 MGprescriptionHuman PrescriptionNorthwind Pharmaceuticals, Llcrepack2014-11-102516550026

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