FDA.reportPublic FDA data

Application 050630

Type
NDA
Sponsor
MERCK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRIMAXINCILASTATIN SODIUM; IMIPENEMPOWDER;INTRAMUSCULAREQ 500MG BASE/VIAL;500MG/VIALNoNo
002PRIMAXINCILASTATIN SODIUM; IMIPENEMPOWDER;INTRAMUSCULAREQ 750MG BASE/VIAL;750MG/VIALNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30194SUPPL2009-11-25
39055SUPPL2009-09-22
30193SUPPL2008-12-19
42660SUPPL2008-08-11
22170SUPPL2008-08-11
22169SUPPL2008-08-11
7909SUPPL2008-04-02
39054SUPPL2008-04-01
42663SUPPL2008-02-19
42662SUPPL2008-02-19
22171SUPPL2008-02-19
30192SUPPL2007-03-31
17955SUPPL2007-03-31
7908SUPPL2006-08-07
7907SUPPL2004-05-26
30191SUPPL2003-03-10
30190SUPPL2001-11-30
42661SUPPL1999-02-04