FDA.reportPublic FDA data

Application 021450

Type
NDA
Sponsor
ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
003ZOMIGZOLMITRIPTANSPRAY;NASAL2.5MG/SPRAYYesNo
004ZOMIGZOLMITRIPTANSPRAY;NASAL5MG/SPRAYYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-955ZOMIGZolmitriptanRebel Distributors CorpNDACurrent
64896-681ZOMIGZolmitriptanAmneal PharmaceuticalsNDACurrent
64896-681ZOMIGZolmitriptanAmneal PharmaceuticalsNDACurrent
64896-681ZOMIGZolmitriptanAmneal PharmaceuticalsNDACurrent
64896-681ZOMIGZolmitriptanImpax Specialty PharmaNDACurrent
64896-681ZOMIGZolmitriptanAmneal PharmaceuticalsNDACurrent
64896-682ZOMIGZolmitriptanAmneal PharmaceuticalsNDACurrent
64896-682ZOMIGZolmitriptanAmneal PharmaceuticalsNDACurrent
64896-682ZOMIGZolmitriptanAmneal PharmaceuticalsNDACurrent
64896-682ZOMIGZolmitriptanImpax Specialty PharmaNDACurrent
64896-682ZOMIGZolmitriptanAmneal PharmaceuticalsNDACurrent
69238-2006ZolmitriptanZolmitriptanAmneal PharmaceuticalsNDA AUTHORIZED GENERICCurrent
69238-2006ZolmitriptanZolmitriptanAmneal PharmaceuticalsNDA AUTHORIZED GENERICCurrent
69238-2007ZolmitriptanZolmitriptanAmneal PharmaceuticalsNDA AUTHORIZED GENERICCurrent
69238-2007ZolmitriptanZolmitriptanAmneal PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57077SUPPL2018-12-31
57032SUPPL2018-12-26
5428SUPPL2015-06-16
36972SUPPL2015-06-15
27832SUPPL2013-09-17
36971SUPPL2013-09-16
5427SUPPL2008-10-21
23662ORIG2007-01-17
21669ORIG2005-04-15
5426SUPPL2004-07-06
15511ORIG2003-10-10
5425ORIG2003-09-30
53449ORIG1900-01-01
53448ORIG1900-01-01
53447ORIG1900-01-01
51500ORIG1900-01-01
51499ORIG1900-01-01