FDA.reportPublic FDA data

Application 208558

Type
NDA
Sponsor
ASTRAZENECA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LYNPARZAOLAPARIBTABLET;ORAL100MGYesNo
002LYNPARZAOLAPARIBTABLET;ORAL150MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0310-0668LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0668LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0668LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0668LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0668LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0668LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0668LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0668LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0668LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0668LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0668LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0668LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0668LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0668LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0668LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0668LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0668LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0668LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0679LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0679LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0679LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0679LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0679LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0679LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0679LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0679LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0679LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0679LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0679LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0679LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0679LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0679LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0679LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0679LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0679LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent
0310-0679LynparzaolaparibAstraZeneca Pharmaceuticals LPNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82820SUPPL 2025-07-11
82819SUPPL 2025-07-11
82804SUPPL 2025-07-11
82790SUPPL 2025-07-11
76526SUPPL 2023-11-08
76521SUPPL 2023-11-07
75422SUPPL 2023-09-13
75415SUPPL 2023-09-13
74421SUPPL 2023-06-01
74415SUPPL 2023-06-01
72511SUPPL2022-10-31
72510SUPPL2022-10-31
72493SUPPL2022-10-28
71953SUPPL2022-08-29
71952SUPPL2022-08-29
71939SUPPL2022-08-29
70505SUPPL2022-03-14
70500SUPPL2022-03-11
70499SUPPL2022-03-11
70054SUPPL2022-02-02
70053SUPPL2022-02-02
70026SUPPL2022-02-01
66772SUPPL2021-03-12
66771SUPPL2021-03-12
66770SUPPL2021-03-12
66758SUPPL2021-03-12
66757SUPPL2021-03-12
65564SUPPL2020-12-10
65563SUPPL2020-12-10
65532SUPPL2020-12-09
65171SUPPL2020-11-09
65136SUPPL2020-11-03
65135SUPPL2020-11-03
63152SUPPL2020-05-20
63151SUPPL2020-05-19
63150SUPPL2020-05-19
62887SUPPL2020-05-11
62860SUPPL2020-05-08
62859SUPPL2020-05-08
61467SUPPL2020-01-10
61468SUPPL2019-12-30
61466SUPPL2019-12-30
60568SUPPL2019-10-15
59292SUPPL2019-07-09
59291SUPPL2019-07-09
59205SUPPL2019-07-02
56948SUPPL2018-12-21
56808SUPPL2018-12-19
55760SUPPL2018-10-01
55633SUPPL2018-09-27
55632SUPPL2018-09-27
52493SUPPL2018-02-07
51059SUPPL2018-01-17
51041SUPPL2018-01-12
49660ORIG2017-09-05
49493ORIG2017-08-21
49444ORIG2017-08-17
49443ORIG2017-08-17