FDA.reportPublic FDA data

Application 021016

Type
NDA
Sponsor
PFIZER IRELAND

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RELPAXELETRIPTAN HYDROBROMIDETABLET;ORALEQ 20MG BASEYesNo
002RELPAXELETRIPTAN HYDROBROMIDETABLET;ORALEQ 40MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0049-2330Relpaxeletriptan hydrobromideRoerigNDACurrent
0049-2330Relpaxeletriptan hydrobromideRoerigNDACurrent
0049-2330Relpaxeletriptan hydrobromideRoerigNDACurrent
0049-2330Relpaxeletriptan hydrobromideRoerigNDACurrent
0049-2330Relpaxeletriptan hydrobromideRoerigNDACurrent
0049-2340Relpaxeletriptan hydrobromideRoerigNDACurrent
0049-2340Relpaxeletriptan hydrobromideRoerigNDACurrent
0049-2340Relpaxeletriptan hydrobromideRoerigNDACurrent
0049-2340Relpaxeletriptan hydrobromideRoerigNDACurrent
0049-2340Relpaxeletriptan hydrobromideRoerigNDACurrent
21695-871Relpaxeletriptan hydrobromideRebel Distributors CorpNDACurrent
59762-2321Eletriptaneletriptan hydrobromideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2321Eletriptaneletriptan hydrobromideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2321Eletriptaneletriptan hydrobromideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2321Eletriptaneletriptan hydrobromideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2321Eletriptaneletriptan hydrobromideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2322Eletriptaneletriptan hydrobromideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2322Eletriptaneletriptan hydrobromideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2322Eletriptaneletriptan hydrobromideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2322Eletriptaneletriptan hydrobromideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2322Eletriptaneletriptan hydrobromideGreenstone LLCNDA AUTHORIZED GENERICCurrent
63539-234Relpaxeletriptan hydrobromideU.S. PharmaceuticalsNDACurrent
63539-234Relpaxeletriptan hydrobromideU.S. PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62332SUPPL2020-03-25
35899SUPPL2013-10-08
26503SUPPL2013-10-08
26502SUPPL2013-10-08
14179SUPPL2013-10-08
14178SUPPL2013-10-08
14177SUPPL2013-10-08
4059SUPPL2013-10-08
4058SUPPL2013-10-08
14176SUPPL2011-04-15
4057SUPPL2011-04-15
35898SUPPL2010-07-31
14175SUPPL2010-07-31
26501SUPPL2010-07-23
4056SUPPL2010-07-23
44087ORIG2007-01-17
26500SUPPL2004-05-07
41878ORIG2003-12-02
35897ORIG2003-04-07
26499ORIG2003-01-29