Application 050585

Type
NDA
Sponsor
HOFFMANN LA ROCHE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROCEPHINCEFTRIAXONE SODIUMINJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002ROCEPHINCEFTRIAXONE SODIUMINJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003ROCEPHINCEFTRIAXONE SODIUMINJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004ROCEPHINCEFTRIAXONE SODIUMINJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
005ROCEPHINCEFTRIAXONE SODIUMINJECTABLE;INJECTIONEQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
006ROCEPHIN KITCEFTRIAXONE SODIUM; LIDOCAINEINJECTABLE;INJECTIONEQ 1GM BASE/VIAL,N/A;N/A,1%NoNo
007ROCEPHIN KITCEFTRIAXONE SODIUM; LIDOCAINEINJECTABLE;INJECTIONEQ 500MG BASE/VIAL,N/A;N/A,1%NoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54905SUPPL2018-07-16
54879SUPPL2018-07-13
7848SUPPL2015-07-08
39008SUPPL2015-07-01
7847SUPPL2015-03-24
17903SUPPL2015-03-23
30121SUPPL2013-04-16
17902SUPPL2013-04-16
30118SUPPL2010-11-18
17900SUPPL2010-11-17
30120SUPPL2010-03-04
17901SUPPL2010-03-03
30119SUPPL2009-06-16
39007SUPPL2009-06-10
17899SUPPL2009-04-03
30117SUPPL2009-03-13
39003SUPPL2008-08-26
17898SUPPL2008-08-26
30116SUPPL2008-08-20
44200ORIG2007-09-11
17897SUPPL2007-07-24
7846SUPPL2007-07-24
39006SUPPL2007-05-16
30115SUPPL2007-05-16
39005SUPPL2004-09-15
30114SUPPL2004-09-15
39004SUPPL2004-09-03
30113SUPPL2004-09-03
7845SUPPL2004-04-07
17896SUPPL2004-04-05