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 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
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.

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
2026-08-01 22:54:32	2026-06	N020815-001	EVISTA	60MG	TABLET / ORAL	AB	RLD, RS	1997-12-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N020815-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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