Erythromycin Delayed Release Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mayne Pharma Inc. (2013-07-17)
Oldest Current Product
1986-12-22
License(s)
NDA AUTHORIZED GENERIC, ANDA
RxNORM
DELAYED RELEASE ORAL CAPSULE\ERYTHROMYCIN
FDAOB
ORAL\CAPSULE, DELAYED RELEASE PELLETS\ERYTHROMYCIN
SPL Active
ORAL\CAPSULE, DELAYED RELEASE PELLETS\ERYTHROMYCIN
ORAL\CAPSULE, DELAYED RELEASE\ERYTHROMYCIN
SPL Moiety
ORAL\CAPSULE, DELAYED RELEASE PELLETS\ERYTHROMYCIN
ORAL\CAPSULE, DELAYED RELEASE\ERYTHROMYCIN

product(s) by strength(s)

erythromycin 250 mg delayed release oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1243380120ANDAArbor Pharmaceuticals, Inc.2012-01-10ERYTHROMYCINORALCAPSULE, DELAYED RELEASEANDA062746ddd9ad9a-fc60-409a-a2b3-be51482ef751
2683080250NDA AUTHORIZED GENERICMayne Pharma Inc.2013-07-29ERYTHROMYCINORALCAPSULE, DELAYED RELEASE PELLETSNDA05053616e754a6-f8e0-4ecf-8300-c55aebe73e33

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790117ANDAKaiser Foundations Hospitals2012-04-26ERYTHROMYCINORALCAPSULE, DELAYED RELEASE243380120ANDA06274651841d8c-5625-448d-8184-940023aebd02
2165900088ANDAStat Rx Usa Llc1986-12-22ERYTHROMYCINORALCAPSULE, DELAYED RELEASE000746301ANDA062746e3e27c8f-64d5-4e6e-bb2d-5dd3a2e3daa1
3545692281ANDAA-S Medication Solutions Llc2012-01-10ERYTHROMYCINORALCAPSULE, DELAYED RELEASE243380120ANDA0627469ffd86da-0e2d-4423-90fd-4e7c69c463dc

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA062338ERYCTrueWARNER CHILCOTT CO LLCANDA062338_001
2ANDA062546ERYCTruePARKE DAVIS DIV WARNER LAMBERT CO1985-07-25ANDA062546_001
3ANDA062618ERYCTruePARKE DAVIS DIV WARNER LAMBERT CO1985-09-25ANDA062618_001
4ANDA062648ERYC 125TruePARKE DAVIS DIV WARNER LAMBERT CO1985-10-24ANDA062648_001
5ANDA062746ERYTHROMYCINARBOR PHARMACEUTICALS LLC1986-12-22ANDA062746_001
6ANDA063098ERYTHROMYCINTrueBARR LABORATORIES INC1989-05-04ANDA063098_001
7NDA050536ERYCMAYNE PHARMA INTERNATIONAL PTY LTDNDA050536_001
8NDA050593ERYC SPRINKLESTrueHOSPIRA INC1985-07-22NDA050593_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA062338_001discontinuedERYTHROMYCIN (250MG)ORALCAPSULE, DELAYED RELEASE PELLETSFalseERYC
2ANDA062546_001discontinuedERYTHROMYCIN (250MG)ORALCAPSULE, DELAYED RELEASE PELLETSFalse1985-07-25ERYC
3ANDA062618_001discontinuedERYTHROMYCIN (250MG)ORALCAPSULE, DELAYED RELEASE PELLETSFalse1985-09-25ERYC
4ANDA062648_001discontinuedERYTHROMYCIN (125MG)ORALCAPSULE, DELAYED RELEASE PELLETSFalse1985-10-24ERYC 125
5ANDA062746_001RXERYTHROMYCIN (250MG)ORALCAPSULE, DELAYED RELEASE PELLETSFalseAB1986-12-22ERYTHROMYCIN
6ANDA063098_001discontinuedERYTHROMYCIN (250MG)ORALCAPSULE, DELAYED RELEASE PELLETSFalse1989-05-04ERYTHROMYCIN
7NDA050536_001RXERYTHROMYCIN (250MG)ORALCAPSULE, DELAYED RELEASE PELLETSTrueABERYC
8NDA050593_001discontinuedERYTHROMYCIN (125MG)ORALCAPSULE, DELAYED RELEASE PELLETSFalse1985-07-22ERYC SPRINKLES

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
116e754a6-f8e0-4ecf-8300-c55aebe73e33 (view SPL)Erythromycin Delayed-Release Capsules, USPprescriptionHuman PrescriptionMayne Pharma Inc.ANALYSIS, MANUFACTURE2013-07-171683080250
251841d8c-5625-448d-8184-940023aebd02 (view SPL)ERYTHROMYCINDELAYED-RELEASECAPSULES, USPprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2012-04-301001790117
39ffd86da-0e2d-4423-90fd-4e7c69c463dc (view SPL)ERYTHROMYCINDELAYED-RELEASECAPSULES, USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-10-061545692281
4ddd9ad9a-fc60-409a-a2b3-be51482ef751 (view SPL)ERYTHROMYCIN DELAYED-RELEASE CAPSULES, USPprescriptionHuman PrescriptionArbor Pharmaceuticals, Inc.2013-11-124243380120
5e3e27c8f-64d5-4e6e-bb2d-5dd3a2e3daa1 (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llc2011-03-022165900088

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