Sulfadiazine Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Eon Labs, Inc. (2013-06-25)
Oldest Current Product
1994-07-29
License(s)
ANDA
RxNORM
ORAL TABLET\SULFADIAZINE
FDAOB
INJECTION\INJECTION\SULFADIAZINE SODIUM\rdfq
ORAL\TABLET\SULFADIAZINE
SPL Active
ORAL\TABLET\SULFADIAZINE
SPL Moiety
ORAL\TABLET\SULFADIAZINE

product(s) by strength(s)

sulfadiazine 500 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001850757ANDAEon Labs, Inc.1994-07-29SULFADIAZINEORALTABLETANDA04009110549cba-9c15-4d2e-a68c-5afbc178591d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1521250226ANDARemedyrepack Inc.2013-02-11SULFADIAZINEORALTABLET001850757ANDA040091d478769c-1137-44a8-a3eb-301ad053c3e7

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040091SULFADIAZINESANDOZ INC1994-07-29ANDA040091_001
2ANDA080081SULFADIAZINETrueIMPAX LABORATORIES INCANDA080081_001
3ANDA080084SULFADIAZINETrueLANNETT CO INCANDA080084_001
4ANDA080088SULFADIAZINETrueEVERYLIFEANDA080088_001
5NDA004054SULFADIAZINETrueLEDERLE LABORATORIES DIV AMERICAN CYANAMID CONDA004054_001, NDA004054_002
6NDA004122SULFADIAZINETrueELI LILLY AND CONDA004122_002
7NDA004125SULFADIAZINETrueABBVIE INCNDA004125_005

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA040091_001RXSULFADIAZINE (500MG)ORALTABLETTrue1994-07-29SULFADIAZINE
2ANDA080081_001discontinuedSULFADIAZINE (500MG)ORALTABLETFalseSULFADIAZINE
3ANDA080084_001discontinuedSULFADIAZINE (500MG)ORALTABLETFalseSULFADIAZINE
4ANDA080088_001discontinuedSULFADIAZINE (500MG)ORALTABLETFalseSULFADIAZINE
5NDA004054_001discontinuedSULFADIAZINE (500MG)ORALTABLETFalseSULFADIAZINE
6NDA004054_002discontinuedSULFADIAZINE SODIUM (250MG/ML)INJECTIONFalseSULFADIAZINE
7NDA004122_002discontinuedSULFADIAZINE (500MG)ORALTABLETFalseSULFADIAZINE
8NDA004125_005discontinuedSULFADIAZINE (300MG)ORALTABLETFalseSULFADIAZINE

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
110549cba-9c15-4d2e-a68c-5afbc178591d (view SPL)SulfADIAZine Tablets USPprescriptionHuman PrescriptionEon Labs, Inc.2013-06-2514001850757
2d478769c-1137-44a8-a3eb-301ad053c3e7 (view SPL)Sulfadiazine Tablets USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-02-112521250226

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