Application 020214

Type
NDA
Sponsor
ORGANON USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZEMURONROCURONIUM BROMIDEINJECTABLE;INJECTION50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002ZEMURONROCURONIUM BROMIDEINJECTABLE;INJECTION10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003ZEMURONROCURONIUM BROMIDEINJECTABLE;INJECTION100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55041SUPPL2018-07-30
55025SUPPL2018-07-27
34376SUPPL2015-01-08
2172SUPPL2015-01-08
2171SUPPL2010-11-30
34375SUPPL2010-11-22
24585SUPPL2008-08-29
12321SUPPL2008-08-29
52325SUPPL2008-04-03
24584SUPPL2004-08-25
24582SUPPL2004-03-03
24583SUPPL2003-06-08
52987SUPPL1900-01-01
52986SUPPL1900-01-01