Etoposide Injectable Solution

Brand(s)
Etopofos, Toposar
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
E.R. Squibb & Sons, L.L.C. (2015-07-30)
Oldest Current Product
1996-08-01
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\ETOPOSIDE
FDAOB
INJECTION\INJECTION\ETOPOSIDE PHOSPHATE\rdfq
INJECTION\INJECTION\ETOPOSIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ETOPOSIDE PHOSPHATE
INTRAVENOUS\INJECTION, SOLUTION\ETOPOSIDE
INTRAVENOUS\INJECTION\ETOPOSIDE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ETOPOSIDE
INTRAVENOUS\INJECTION, SOLUTION\ETOPOSIDE
INTRAVENOUS\INJECTION\ETOPOSIDE

product(s) by strength(s)

etoposide 20 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000153404EtopofosNDAE.R. Squibb & Sons, L.L.C.2009-06-01ETOPOSIDE PHOSPHATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA020457e28c05f0-081f-406d-8bfb-9160a6908307

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007035653ToposarANDATeva Parenteral Medicines, Inc1996-08-01ETOPOSIDEINTRAVENOUSINJECTIONANDA074529c9080cf5-4fc3-4cf9-a241-6e40a6fddc75
2007035656ToposarANDATeva Parenteral Medicines, Inc1996-08-01ETOPOSIDEINTRAVENOUSINJECTIONANDA07452917e94672-4f1c-443b-8da6-bfa6cc96e485, c9080cf5-4fc3-4cf9-a241-6e40a6fddc75
3007035657ToposarANDATeva Parenteral Medicines, Inc1997-05-01ETOPOSIDEINTRAVENOUSINJECTIONANDA07452917e94672-4f1c-443b-8da6-bfa6cc96e485, c9080cf5-4fc3-4cf9-a241-6e40a6fddc75
4167290114ANDAAccord Healthcare Inc.2013-09-15ETOPOSIDEINTRAVENOUSINJECTIONANDA0745134f850eb2-3542-43a0-90e8-bb37fa05cf15
5167290262ANDAAccord Healthcare Inc.2013-08-01ETOPOSIDEINTRAVENOUSINJECTIONANDA074513003ce7e0-f787-469d-8b44-3c2acdcae6d7
6633230104ANDAApp Pharmaceuticals, Llc2001-07-18ETOPOSIDEINTRAVENOUSINJECTION, SOLUTIONANDA074983fe870629-104d-4d67-a7c6-f53bc588121e
7680010265ANDABluepoint Laboratories2013-11-14ETOPOSIDEINTRAVENOUSINJECTIONANDA074513157d4e0f-806d-4011-9dec-97e2449e507b

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074166TOPOSARTrueTEVA PARENTERAL MEDICINES INC1995-02-27ANDA074166_001
2ANDA074227ETOPOSIDETruePHARMACHEMIE BV1996-02-22ANDA074227_001
3ANDA074228ETOPOSIDETrueWATSON LABORATORIES INC1996-10-15ANDA074228_001
4ANDA074284ETOPOSIDETrueTEVA PHARMACEUTICALS USA1994-02-10ANDA074284_001
5ANDA074290ETOPOSIDEEUROHEALTH INTERNATIONAL SARL1995-07-17ANDA074290_001
6ANDA074320ETOPOSIDETrueHOSPIRA INC1995-08-30ANDA074320_001
7ANDA074351ETOPOSIDETrueHOSPIRA INC1995-08-30ANDA074351_001
8ANDA074510ETOPOSIDETrueTEVA PARENTERAL MEDICINES INC1995-06-29ANDA074510_001
9ANDA074513ETOPOSIDEACCORD HEALTHCARE INC1996-03-14ANDA074513_001
10ANDA074529ETOPOSIDETEVA PHARMACEUTICALS USA1996-07-24ANDA074529_001
11ANDA074813ETOPOSIDETruePIERRE FABRE MEDICAMENT1997-07-09ANDA074813_001
12ANDA074968ETOPOSIDETrueWATSON LABORATORIES INC1998-01-09ANDA074968_001
13ANDA074983ETOPOSIDEFRESENIUS KABI USA LLC1998-09-30ANDA074983_001
14NDA018768VEPESIDTrueCORDEN PHARMA LATINA SPA1983-11-10NDA018768_001
15NDA020457ETOPOPHOS PRESERVATIVE FREEBRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE1996-05-17NDA020457_001
16NDA020906ETOPOPHOS PRESERVATIVE FREETrueBRISTOL MYERS SQUIBB1998-02-27NDA020906_001, NDA020906_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA074166_001discontinuedETOPOSIDE (20MG/ML)INJECTIONFalse1995-02-27TOPOSAR
2ANDA074227_001discontinuedETOPOSIDE (20MG/ML)INJECTIONFalse1996-02-22ETOPOSIDE
3ANDA074228_001discontinuedETOPOSIDE (20MG/ML)INJECTIONFalse1996-10-15ETOPOSIDE
4ANDA074284_001discontinuedETOPOSIDE (20MG/ML)INJECTIONFalse1994-02-10ETOPOSIDE
5ANDA074290_001RXETOPOSIDE (20MG/ML)INJECTIONFalseAP1995-07-17ETOPOSIDE
6ANDA074320_001discontinuedETOPOSIDE (20MG/ML)INJECTIONFalse1995-08-30ETOPOSIDE
7ANDA074351_001discontinuedETOPOSIDE (20MG/ML)INJECTIONFalse1995-08-30ETOPOSIDE
8ANDA074510_001discontinuedETOPOSIDE (20MG/ML)INJECTIONFalse1995-06-29ETOPOSIDE
9ANDA074513_001RXETOPOSIDE (20MG/ML)INJECTIONFalseAP1996-03-14ETOPOSIDE
10ANDA074529_001RXETOPOSIDE (20MG/ML)INJECTIONFalseAP1996-07-24ETOPOSIDE
11ANDA074813_001discontinuedETOPOSIDE (20MG/ML)INJECTIONFalse1997-07-09ETOPOSIDE
12ANDA074968_001discontinuedETOPOSIDE (20MG/ML)INJECTIONFalse1998-01-09ETOPOSIDE
13ANDA074983_001RXETOPOSIDE (20MG/ML)INJECTIONTrueAP1998-09-30ETOPOSIDE
14NDA018768_001discontinuedETOPOSIDE (20MG/ML)INJECTIONFalse1983-11-10VEPESID
15NDA020457_001RXETOPOSIDE PHOSPHATE (EQ 100MG BASE/VIAL)INJECTIONTrue1996-05-17ETOPOPHOS PRESERVATIVE FREE
16NDA020906_001discontinuedETOPOSIDE PHOSPHATE (EQ 500MG BASE/VIAL)INJECTIONFalse1998-02-27ETOPOPHOS PRESERVATIVE FREE
17NDA020906_002discontinuedETOPOSIDE PHOSPHATE (EQ 1GM BASE/VIAL)INJECTIONFalse1998-02-27ETOPOPHOS PRESERVATIVE FREE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1003ce7e0-f787-469d-8b44-3c2acdcae6d7 (view SPL)NOVAPLUS ETOPOSIDE INJECTION USPprescriptionHuman PrescriptionAccord Healthcare Inc.analysis, manufacture2013-08-011167290262
2157d4e0f-806d-4011-9dec-97e2449e507b (view SPL)ETOPOSIDE INJECTION USPprescriptionHuman PrescriptionBluepoint LaboratoriesANALYSIS, MANUFACTURE2015-05-262680010265
317e94672-4f1c-443b-8da6-bfa6cc96e485 (view SPL)Toposar (Etoposide Injection, USP)prescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2013-05-101007035656, 007035657
44f850eb2-3542-43a0-90e8-bb37fa05cf15 (view SPL)ETOPOSIDE INJECTION USPprescriptionHuman PrescriptionAccord Healthcare Inc.analysis, manufacture2015-05-073167290114
5c9080cf5-4fc3-4cf9-a241-6e40a6fddc75 (view SPL)Toposar (Etoposide Injection, USP)prescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2012-08-145007035653, 007035656, 007035657
6e28c05f0-081f-406d-8bfb-9160a6908307 (view SPL)ETOPOPHOS (etoposide phosphate)for INJECTIONprescriptionHuman PrescriptionE.R. Squibb & Sons, L.L.C.2015-07-307000153404
7fe870629-104d-4d67-a7c6-f53bc588121e (view SPL)Etoposide Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2012-08-301633230104

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