Neomycin Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2015-11-19)
Oldest Current Product
1990-09-30
License(s)
ANDA
RxNORM
ORAL TABLET\NEOMYCIN
FDAOB
ORAL\TABLET\NEOMYCIN SULFATE
SPL Active
ORAL\TABLET\NEOMYCIN SULFATE
SPL Moiety
ORAL\TABLET\NEOMYCIN

product(s) by strength(s)

neomycin sulfate 500 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000931177ANDATeva Pharmaceuticals Usa Inc1990-09-30NEOMYCIN SULFATEORALTABLETANDA060304777dbfab-f83e-4738-ae1e-78619a9f82a7
2009045941ANDAMajor2009-09-14NEOMYCIN SULFATEORALTABLETANDA06030457337e50-5c37-4690-a146-5274c22ba2ec
3398220310ANDAX-Gen Pharmaceuticals, Inc.2010-03-12NEOMYCIN SULFATEORALTABLETANDA065220a35a558c-7d96-43fb-917b-475189772edd
4503830565ANDAHi-Tech Pharmacal Co., Inc.2010-03-12NEOMYCIN SULFATEORALTABLETANDA0652200e8ee79e-1301-44b3-be45-0194afc731b6
5519910738ANDABreckenridge Pharmaceutical, Inc.2011-01-03NEOMYCIN SULFATEORALTABLETANDA065468f594cca9-6a73-44f3-9093-67af09567cb8

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1604290239ANDAGolden State Medical Supply, Inc.2011-01-03NEOMYCIN SULFATEORALTABLET519910738ANDA0654681554b8d1-637e-4059-8366-18a544610dd6

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA060304NEOMYCIN SULFATETEVA PHARMACEUTICALS USA INCANDA060304_001
2ANDA060365NEOMYCIN SULFATETrueBRISTOL MYERS SQUIBB COANDA060365_001
3ANDA060385NEOMYCIN SULFATETrueELI LILLY AND COANDA060385_001
4ANDA060475NEOBIOTICTruePFIZER LABORATORIES DIV PFIZER INCANDA060475_001
5ANDA060520MYCIFRADINTruePHARMACIA AND UPJOHN COANDA060520_001
6ANDA060607NEOMYCIN SULFATETrueLANNETT CO INCANDA060607_001
7ANDA061586NEOMYCIN SULFATETrueSANDOZ INCANDA061586_001
8ANDA062173NEOMYCIN SULFATETrueROXANE LABORATORIES INCANDA062173_001
9ANDA065220NEOMYCIN SULFATEX GEN PHARMACEUTICALS INC2006-07-28ANDA065220_001
10ANDA065468NEOMYCIN SULFATEOMAN PHARMACEUTICAL PRODUCTS CO LLC2010-03-29ANDA065468_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA060304_001RXNEOMYCIN SULFATE (500MG)ORALTABLETTrueAANEOMYCIN SULFATE
2ANDA060365_001discontinuedNEOMYCIN SULFATE (500MG)ORALTABLETFalseNEOMYCIN SULFATE
3ANDA060385_001discontinuedNEOMYCIN SULFATE (500MG)ORALTABLETFalseNEOMYCIN SULFATE
4ANDA060475_001discontinuedNEOMYCIN SULFATE (EQ 350MG BASE)ORALTABLETFalseNEOBIOTIC
5ANDA060520_001discontinuedNEOMYCIN SULFATE (EQ 350MG BASE)ORALTABLETFalseMYCIFRADIN
6ANDA060607_001discontinuedNEOMYCIN SULFATE (500MG)ORALTABLETFalseNEOMYCIN SULFATE
7ANDA061586_001discontinuedNEOMYCIN SULFATE (500MG)ORALTABLETFalseNEOMYCIN SULFATE
8ANDA062173_001discontinuedNEOMYCIN SULFATE (500MG)ORALTABLETFalseNEOMYCIN SULFATE
9ANDA065220_001RXNEOMYCIN SULFATE (500MG)ORALTABLETFalseAA2006-07-28NEOMYCIN SULFATE
10ANDA065468_001RXNEOMYCIN SULFATE (500MG)ORALTABLETFalseAA2010-03-29NEOMYCIN SULFATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10e8ee79e-1301-44b3-be45-0194afc731b6 (view SPL)Neomycin Sulfate Tablets, USP 500 mg (equivalent to 350 mg of neomycin base per tablet) Rx Only To reduce the development of drug-resistant bacteria and maintain the effectiveness of neomycin sulfate tablets and other antibacterial drugs, neomycin sulfate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.prescriptionHuman PrescriptionHi-Tech Pharmacal Co., Inc.ANALYSIS, MANUFACTURE2010-03-101503830565
21554b8d1-637e-4059-8366-18a544610dd6 (view SPL)NEOMYCIN SULFATE TABLETS USP, 500 MGprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2012-01-091604290239
357337e50-5c37-4690-a146-5274c22ba2ec (view SPL)NEOMYCIN SULFATE TABLETS USP, 500 MG1177prescriptionHuman PrescriptionMajor2009-09-301009045941
4777dbfab-f83e-4738-ae1e-78619a9f82a7 (view SPL)NEOMYCIN SULFATE TABLETS USP, 500 MG 1177Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-11-196000931177
5a35a558c-7d96-43fb-917b-475189772edd (view SPL)Neomycin Sulfate Tablets, USP 500 mg (equivalent to 350 mg of neomycin base per tablet) Rx Only To reduce the development of drug-resistant bacteria and maintain the effectiveness of neomycin sulfate tablets and other antibacterial drugs, neomycin sulfate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.prescriptionHuman PrescriptionX-Gen Pharmaceuticals, Inc.2012-04-167398220310
6f594cca9-6a73-44f3-9093-67af09567cb8 (view SPL)NEOMYCIN SULFATE TABLETS USP, 500 MGprescriptionHuman PrescriptionBreckenridge Pharmaceutical, Inc.MANUFACTURE, PACK2010-12-232519910738

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