Home Applications 020815 Application 020815
Type NDA
Sponsor LILLY Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EVISTA RALOXIFENE HYDROCHLORIDE TABLET;ORAL 60MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N020815-001 EVISTA RALOXIFENE HYDROCHLORIDE 60MG TABLET / ORAL AB RLD, RS 1997-12-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020815-001 AB
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 · 42 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 2026-08-18 06:07:40 2026-07 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020815-001 EVISTA 60MG TABLET / ORAL AB RLD, RS 1997-12-09 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Evista RALOXIFENE HYDROCHLORIDE Eli Lilly and Company fcaaa6dc-74e8-4fb8-800c-5574bf0f8de9 2025-07-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020815 application number: NDA020815 ndc (product): 0002-4184
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0002-4184 Evista Raloxifene hydrochloride Eli Lilly and Company NDA Current 0002-4184 Evista Raloxifene hydrochloride Eli Lilly and Company NDA Current 0002-4184 Evista Raloxifene hydrochloride Eli Lilly and Company NDA Current 0002-4184 Evista Raloxifene hydrochloride Eli Lilly and Company NDA Current 0002-4184 Evista Raloxifene hydrochloride Eli Lilly and Company NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 54842 SUPPL 2018-07-06 54755 SUPPL 2018-07-05 41718 ORIG 2009-12-03 43680 ORIG 2009-11-18 3407 SUPPL 2007-09-25 35397 SUPPL 2007-07-24 25888 SUPPL 2007-07-24 41719 SUPPL 1999-09-30 25887 SUPPL 1999-09-30 13471 SUPPL 1999-09-30 20973 SUPPL 1998-11-24