FDA.reportPublic FDA data

Application 076703

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)DESMOPRESSIN ACETATESPRAY, METERED;NASAL0.01MG/SPRAYNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-0815DESMOPRESSIN ACETATEDESMOPRESSIN ACETATEApotex Corp.ANDACurrent
60505-0815DESMOPRESSIN ACETATEDESMOPRESSIN ACETATEApotex Corp.ANDACurrent
60505-0815DESMOPRESSIN ACETATEDESMOPRESSIN ACETATEApotex Corp.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22582ORIG2007-10-11
8952ORIG2005-01-27