Application 078378

Type
ANDA
Sponsor
US WORLDMEDS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REVONTODANTROLENE SODIUMINJECTABLE;INJECTION20MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27505-003Revontodantrolene sodiumUS WorldMeds, LLCANDACurrent
27505-003Revontodantrolene sodiumUS WorldMeds, LLCANDACurrent
27505-003Revontodantrolene sodiumUS WorldMeds, LLCANDACurrent
78670-003Revontodantrolene sodiumUSWM, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9151ORIG2007-07-27