FDA.reportPublic FDA data

Application 212907

Type
ANDA
Sponsor
CIPLA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIHYDROERGOTAMINE MESYLATEDIHYDROERGOTAMINE MESYLATESPRAY, METERED;NASAL0.5MG/SPRAYNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69097-503Dihydroergotamine Mesylate NasalDihydroergotamine Mesylate NasalCipla USA Inc.ANDACurrent
69097-503Dihydroergotamine Mesylate NasalDihydroergotamine Mesylate NasalCipla USA Inc.ANDACurrent
69097-503Dihydroergotamine Mesylate NasalDihydroergotamine Mesylate NasalCipla USA Inc.ANDACurrent
69097-503Dihydroergotamine Mesylate NasalDihydroergotamine Mesylate NasalCipla USA Inc.ANDACurrent
69097-740Dihydroergotamine Mesylate NasalDihydroergotamine Mesylate NasalCipla USA Inc.ANDACurrent
69097-740Dihydroergotamine Mesylate NasalDihydroergotamine Mesylate NasalCipla USA Inc.ANDACurrent
69097-740Dihydroergotamine Mesylate NasalDihydroergotamine Mesylate NasalCipla USA Inc.ANDACurrent
76282-680Dihydroergotamine Mesylate NasalDihydroergotamine Mesylate NasalExelan Pharmaceuticals, Inc.ANDACurrent
76282-680Dihydroergotamine Mesylate NasalDihydroergotamine Mesylate NasalExelan Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63453ORIG2020-06-08