Thiotepa Injection

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
West-Ward Pharmaceutical Corp (2015-01-27)
Oldest Current Product
2001-06-01
License(s)
ANDA
RxNORM
INJECTION\THIOTEPA
FDAOB
INJECTION\INJECTION\THIOTEPA\rdfq
SPL Active
INTRACAVITARY\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\THIOTEPA
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\THIOTEPA
SPL Moiety
INTRACAVITARY\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\THIOTEPA
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\THIOTEPA

product(s) by strength(s)

thiotepa 100 mg injection

product(s)(s)

#idlabelerfirst marketedactive ingredient(s)routedose formspl
1539640002Adienne Sa2011-04-05THIOTEPAINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONb3d8195b-3ed9-4931-bc59-b8a61ca64408

thiotepa 15 mg injection

original product(s)(s)

#idlabelerfirst marketedactive ingredient(s)routedose formspl
1539640001Adienne Sa2011-04-05THIOTEPAINTRAVENOUSINJECTION, POWDER, FOR SOLUTION89a11272-62a6-45d6-9ace-ea55de178dc3

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439565ANDAWest-Ward Pharmaceutical Corp2001-06-01THIOTEPAINTRACAVITARYINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA075547b19b03db-471d-4ee7-b1b8-6eccc39c41b0

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075547THIOTEPAEUROHEALTH INTERNATIONAL SARL2001-04-02ANDA075547_001
2ANDA075698THIOTEPATrueFRESENIUS KABI USA LLC2001-09-20ANDA075698_001
3ANDA075730THIOTEPATrueTEVA PARENTERAL MEDICINES INC2001-04-20ANDA075730_001, ANDA075730_002
4NDA011683THIOTEPATrueIMMUNEX CORPNDA011683_001
5NDA020058THIOPLEXTrueIMMUNEX CORP1994-12-22NDA020058_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1ANDA075547_001RXTHIOTEPA (15MG/VIAL)INJECTIONTrue2001-04-02THIOTEPA
2ANDA075698_001discontinuedTHIOTEPA (15MG/VIAL)INJECTIONFalse2001-09-20THIOTEPA
3ANDA075730_001discontinuedTHIOTEPA (15MG/VIAL)INJECTIONFalse2001-04-20THIOTEPA
4ANDA075730_002discontinuedTHIOTEPA (30MG/VIAL)INJECTIONFalse2001-04-20THIOTEPA
5NDA011683_001discontinuedTHIOTEPA (15MG/VIAL)INJECTIONFalseTHIOTEPA
6NDA020058_001discontinuedTHIOTEPA (15MG/VIAL)INJECTIONFalse1994-12-22THIOPLEX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
189a11272-62a6-45d6-9ace-ea55de178dc3 (view SPL)TEPADINA 15 mg powder for concentrate for solution for infusionprescriptionHuman PrescriptionAdienne SaANALYSIS, API MANUFACTURE, MANUFACTURE2012-12-051539640001
2b19b03db-471d-4ee7-b1b8-6eccc39c41b0 (view SPL)THIOTEPA FOR INJECTION, USPprescriptionHuman PrescriptionWest-Ward Pharmaceutical Corp2015-01-271001439565
3b3d8195b-3ed9-4931-bc59-b8a61ca64408 (view SPL)TEPADINA 100 mg powder for concentrate for solution for infusionprescriptionHuman PrescriptionAdienne SaANALYSIS, API MANUFACTURE, MANUFACTURE2012-12-051539640002

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