Home Applications 206162 Application 206162
Type NDA
Sponsor ASTRAZENECA PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LYNPARZA OLAPARIB CAPSULE;ORAL 50MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N206162-001 LYNPARZA OLAPARIB 50MG CAPSULE / ORAL RLD 2014-12-19
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206162-001 8143241 2027-08-12 U-1634 2015-01-15 N206162-001 8247416 2028-09-24 Drug substance 2015-01-15 N206162-001 8859562 2031-08-04 U-1634 2015-01-15
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD, RS 2014-12-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD, RS 2014-12-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD, RS 2014-12-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD, RS 2014-12-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD, RS 2014-12-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N206162-001 LYNPARZA 50MG CAPSULE / ORAL RLD 2014-12-19 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 7 · 246 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N206162-001 8143241 2027-08-12 U-1634 2015-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206162-001 8247416 2028-09-24 Drug substance 2015-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206162-001 8859562 2031-08-04 U-1634 2015-01-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206162-001 8143241 2027-08-12 U-1634 2015-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206162-001 8247416 2028-09-24 Drug substance 2015-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206162-001 8859562 2031-08-04 U-1634 2015-01-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206162-001 8143241 2027-08-12 U-1634 2015-01-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206162-001 8247416 2028-09-24 Drug substance 2015-01-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206162-001 8859562 2031-08-04 U-1634 2015-01-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206162-001 8143241 2027-08-12 U-1634 2015-01-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206162-001 8247416 2028-09-24 Drug substance 2015-01-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206162-001 8859562 2031-08-04 U-1634 2015-01-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206162-001 8143241 2027-08-12 U-1634 2015-01-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206162-001 8247416 2028-09-24 Drug substance 2015-01-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206162-001 8859562 2031-08-04 U-1634 2015-01-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206162-001 8912187 2024-03-12 U-1634 2015-01-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206162-001 7449464 2024-10-11 Drug substance, Drug product 2015-01-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206162-001 7981889 2024-10-11 Drug substance, Drug product 2015-01-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206162-001 8143241 2027-08-12 U-1634 2015-01-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206162-001 8247416 2028-09-24 Drug substance 2015-01-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206162-001 8859562 2031-08-04 U-1634 2015-01-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206162-001 8912187 2024-03-12 U-1634 2015-01-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206162-001 7449464 2024-10-11 Drug substance, Drug product 2015-01-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206162-001 7981889 2024-10-11 Drug substance, Drug product 2015-01-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206162-001 8143241 2027-08-12 U-1634 2015-01-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206162-001 8247416 2028-09-24 Drug substance 2015-01-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206162-001 8859562 2031-08-04 U-1634 2015-01-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206162-001 8912187 2024-03-12 U-1634 2015-01-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206162-001 7449464 2024-10-11 Drug substance, Drug product 2015-01-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206162-001 7981889 2024-10-11 Drug substance, Drug product 2015-01-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206162-001 8143241 2027-08-12 U-1634 2015-01-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206162-001 8247416 2028-09-24 Drug substance 2015-01-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206162-001 8859562 2031-08-04 U-1634 2015-01-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206162-001 8912187 2024-03-12 U-1634 2015-01-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206162-001 7449464 2024-10-11 Drug substance, Drug product 2015-01-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206162-001 7981889 2024-10-11 Drug substance, Drug product 2015-01-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206162-001 8143241 2027-08-12 U-1634 2015-01-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206162-001 8247416 2028-09-24 Drug substance 2015-01-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206162-001 8859562 2031-08-04 U-1634 2015-01-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206162-001 8912187 2024-03-12 U-1634 2015-01-15 d06236e962d9…
Observed Orange Book exclusivity history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0310-0657 Lynparza olaparib AstraZeneca Pharmaceuticals LP NDA Current