Chloramphenicol Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
App Pharmaceuticals, Llc (2013-05-16)
Oldest Current Product
2001-01-12
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\CHLORAMPHENICOL
FDAOB
INJECTION\INJECTION\CHLORAMPHENICOL SODIUM SUCCINATE\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\CHLORAMPHENICOL SODIUM SUCCINATE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\CHLORAMPHENICOL

product(s) by strength(s)

chloramphenicol 100 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230011ANDAApp Pharmaceuticals, Llc2001-01-12CHLORAMPHENICOL SODIUM SUCCINATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA062365aed29594-211d-49ef-813f-131975a8d0e3

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840011ANDAGeneral Injecatables & Vaccines, Inc2010-09-01CHLORAMPHENICOL SODIUM SUCCINATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION633230011ANDA06236508c16a42-1ad4-400f-b1b0-75303eb86713

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA060132MYCHEL-STrueANGUS CHEMICAL COANDA060132_001
2ANDA062278CHLORAMPHENICOL SODIUM SUCCINATETrueGRUPPO LEPETIT SPA SUB MERRELL DOW PHARMACEUTICALS INCANDA062278_001
3ANDA062365CHLORAMPHENICOL SODIUM SUCCINATEFRESENIUS KABI USA LLC1982-08-25ANDA062365_001
4ANDA062406CHLORAMPHENICOLTrueELKINS SINN DIV AH ROBINS CO INC1982-11-09ANDA062406_001
5NDA050155CHLOROMYCETINTruePARKEDALE PHARMACEUTICALS INCNDA050155_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1ANDA060132_001discontinuedCHLORAMPHENICOL SODIUM SUCCINATE (EQ 1GM BASE/VIAL)INJECTIONFalseMYCHEL-S
2ANDA062278_001discontinuedCHLORAMPHENICOL SODIUM SUCCINATE (EQ 1GM BASE/VIAL)INJECTIONFalseCHLORAMPHENICOL SODIUM SUCCINATE
3ANDA062365_001RXCHLORAMPHENICOL SODIUM SUCCINATE (EQ 1GM BASE/VIAL)INJECTIONTrue1982-08-25CHLORAMPHENICOL SODIUM SUCCINATE
4ANDA062406_001discontinuedCHLORAMPHENICOL SODIUM SUCCINATE (EQ 1GM BASE/VIAL)INJECTIONFalse1982-11-09CHLORAMPHENICOL
5NDA050155_001discontinuedCHLORAMPHENICOL SODIUM SUCCINATE (EQ 1GM BASE/VIAL)INJECTIONFalseCHLOROMYCETIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
108c16a42-1ad4-400f-b1b0-75303eb86713 (view SPL)Chloramphenicol Sodium Succinate 1 gm Injection, USP 1 gm VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-09-081525840011
2aed29594-211d-49ef-813f-131975a8d0e3 (view SPL)CHLORAMPHENICOL SODIUM SUCCINATEprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2013-05-162633230011

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