FDA.reportPublic FDA data

Application 210868

Type
NDA
Sponsor
PFIZER INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LORBRENALORLATINIBTABLET;ORAL25MGYesNo
002LORBRENALORLATINIBTABLET;ORAL100MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0227LorbrenalorlatinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0227LorbrenalorlatinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0227LorbrenalorlatinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0227LorbrenalorlatinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0227LorbrenalorlatinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0227LorbrenalorlatinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0231LorbrenalorlatinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0231LorbrenalorlatinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0231LorbrenalorlatinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0231LorbrenalorlatinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0231LorbrenalorlatinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0231LorbrenalorlatinibPfizer Laboratories Div Pfizer IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84946SUPPL 2026-02-05
84884SUPPL 2026-01-30
83607SUPPL 2025-09-30
83606SUPPL 2025-09-30
66489SUPPL2021-03-04
66478SUPPL2021-03-03
66444SUPPL2021-03-02
66435SUPPL2021-03-01
66001SUPPL2021-01-26
65992SUPPL2021-01-26
63398SUPPL2020-06-02
63390SUPPL2020-06-02
56695ORIG2018-12-10
56424ORIG2018-11-13
56252ORIG2018-11-02