FDA.report

Application 212728

Type
NDA
Sponsor
BIOHAVEN PHARM

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001NURTEC ODTRIMEGEPANT SULFATETABLET, ORALLY DISINTEGRATING;ORALEQ 75MG BASEYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
72618-3000NURTEC ODTrimegepant sulfateBiohaven Pharmaceuticals, IncNDACurrent
72618-3000NURTEC ODTrimegepant sulfateBiohaven Pharmaceuticals, IncNDACurrent
72618-3000NURTEC ODTrimegepant sulfateBiohaven Pharmaceuticals, IncNDACurrent
72618-3000NURTEC ODTrimegepant sulfateBiohaven Pharmaceuticals, IncNDACurrent
72618-3000NURTEC ODTrimegepant sulfateBiohaven Pharmaceuticals, IncNDACurrent
72618-3000NURTEC ODTrimegepant sulfateBiohaven Pharmaceuticals, IncNDACurrent
72618-3000NURTEC ODTrimegepant sulfateBiohaven Pharmaceuticals, IncNDACurrent
72618-3000NURTEC ODTrimegepant sulfateBiohaven Pharmaceuticals, IncNDACurrent
72618-3000NURTEC ODTrimegepant sulfateBiohaven Pharmaceuticals, IncNDACurrent
72618-3000NURTEC ODTrimegepant sulfateBiohaven Pharmaceuticals, IncNDACurrent
72618-3000NURTEC ODTrimegepant sulfateBiohaven Pharmaceuticals, IncNDACurrent
72618-3000NURTEC ODTrimegepant sulfateBiohaven Pharmaceuticals, IncNDACurrent
72618-3000NURTEC ODTrimegepant sulfateBiohaven Pharmaceuticals, IncNDACurrent
72618-3000NURTEC ODTrimegepant sulfateBiohaven Pharmaceuticals, IncNDACurrent

Documents

DocumentSubmission typeDate
85870SUPPL 2026-05-11
85862SUPPL 2026-05-11
85470SUPPL 2026-03-24
85405SUPPL 2026-03-19
83049SUPPL 2025-08-05
83040SUPPL 2025-08-04
81714SUPPL 2025-03-25
81698SUPPL 2025-03-24
80570SUPPL 2025-01-02
80569SUPPL 2025-01-02
71458SUPPL2022-06-27
70762SUPPL2022-04-14
70753SUPPL2022-04-12
69527SUPPL2021-12-10
69519SUPPL2021-12-09
67634SUPPL2021-06-01
67625SUPPL2021-05-28
64303SUPPL2020-08-19
64298SUPPL2020-08-19
62340ORIG2020-03-26
61991ORIG2020-02-28
61988ORIG2020-02-27