FDA.reportPublic FDA data

Application 020148

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIGRANALDIHYDROERGOTAMINE MESYLATESPRAY, METERED;NASAL0.5MG/SPRAYYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-0245Migranaldihydroergotamine mesylateValeant Pharmaceuticals North America LLCNDACurrent
0187-0245Migranaldihydroergotamine mesylateBausch Health US, LLCNDACurrent
0187-0245Migranaldihydroergotamine mesylateBausch Health US, LLCNDACurrent
0187-0245Migranaldihydroergotamine mesylateBausch Health US, LLCNDACurrent
0187-0245Migranaldihydroergotamine mesylateValeant Pharmaceuticals North America LLCNDACurrent
0187-0245Migranaldihydroergotamine mesylateBausch Health US, LLCNDACurrent
0187-0245Migranaldihydroergotamine mesylateBausch Health US, LLCNDACurrent
68682-357Dihydroergotamine Mesylatedihydroergotamine mesylateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-357Dihydroergotamine Mesylatedihydroergotamine mesylateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-357Dihydroergotamine Mesylatedihydroergotamine mesylateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-357Dihydroergotamine Mesylatedihydroergotamine mesylateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71043SUPPL2022-05-11
71030SUPPL2022-05-10
59974SUPPL2019-09-11
59563SUPPL2019-08-02
41156ORIG2010-05-25
34298SUPPL2002-07-31
21209SUPPL2002-07-31
12250SUPPL2002-07-31
2065SUPPL2002-07-31