Application 206995

Type
NDA
Sponsor
ASTRAZENECA PHARMS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001IRESSAGEFITINIBTABLET;ORAL250MGYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0310-0482IRESSAGefitinibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0482IRESSAGefitinibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0482IRESSAGefitinibAstraZeneca Pharmaceuticals LPNDACurrent

Documents

DocumentSubmission typeDate
67431SUPPL2021-05-07
67419SUPPL2021-05-06
55313SUPPL2018-08-24
55273SUPPL2018-08-23
23029ORIG2016-07-28
10605ORIG2015-07-15
19953ORIG2015-07-13