FDA.reportPublic FDA data

Application 091345

Type
ANDA
Sponsor
ZYDUS PHARMS

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
68382-384Desmopressin AcetateDesmopressin AcetateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-384Desmopressin AcetateDesmopressin AcetateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-384Desmopressin AcetateDesmopressin AcetateZydus Pharmaceuticals USA Inc.ANDACurrent
70771-1314Desmopressin AcetateDesmopressin AcetateCadila Healthcare LimitedANDACurrent
70771-1314Desmopressin AcetateDesmopressin AcetateCadila Healthcare LimitedANDACurrent
70771-1314Desmopressin AcetateDesmopressin AcetateCadila Healthcare LimitedANDACurrent
70771-1314Desmopressin AcetateDesmopressin AcetateZydus Lifesciences LimitedANDACurrent