Application 200825

Type: ANDA
Sponsor: WATSON LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	TABLET;ORAL	60MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A200825-001	RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB		2015-01-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A200825-001	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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200825-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-01-21	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A200825-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200825-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200825-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200825-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200825-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200825-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200825-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200825-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200825-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200825-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200825-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200825-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200825-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200825-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200825-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200825-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200825-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200825-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200825-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200825-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200825-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200825-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200825-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200825-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200825-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200825-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200825-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200825-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200825-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200825-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200825-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200825-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200825-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200825-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200825-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200825-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200825-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200825-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200825-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200825-001	AB	1	`f41ea6bd6efb…`

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Raloxifene Hydrochloride	RALOXIFENE HYDROCHLORIDE	Amneal Pharmaceuticals LLC	3798c70b-a4b0-4811-9788-e4c9cff47ebe	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Raloxifene Hydrochloride generic name: RALOXIFENE HYDROCHLORIDE
Evista	RALOXIFENE HYDROCHLORIDE	Eli Lilly and Company	fcaaa6dc-74e8-4fb8-800c-5574bf0f8de9	2026-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene Hydrochloride	RALOXIFENE HYDROCHLORIDE	AvPAK	6f7eb934-aa60-51e1-e053-2a91aa0a3914	2026-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Raloxifene Hydrochloride generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene Hydrochloride	RALOXIFENE HYDROCHLORIDE	A-S Medication Solutions	804e873e-f48b-4c25-ad7b-41d44f61bdde	2025-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Raloxifene Hydrochloride generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene hydrochloride	RALOXIFENE HYDROCHLORIDE	Major Pharmaceuticals	e2967d3c-238c-40cf-b3d8-89482a502928	2025-03-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Raloxifene hydrochloride generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene hydrochloride	RALOXIFENE HYDROCHLORIDE	Bryant Ranch Prepack	7e4bfee5-fefc-4115-9bdb-222eccefca83	2024-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Raloxifene hydrochloride generic name: RALOXIFENE HYDROCHLORIDE
raloxifene hydrochloride	RALOXIFENE HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	c05521f8-95d2-44b8-8433-eba539c0f84c	2024-05-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: raloxifene hydrochloride generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene Hydrochloride	RALOXIFENE	American Health Packaging	f5c25553-1546-451d-8069-c0f484c47741	2024-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Raloxifene Hydrochloride
Raloxifene Hydrochloride	RALOXIFENE HYDROCHLORIDE	Bryant Ranch Prepack	5a22ae27-1c55-487b-8e93-8ef1cec87065	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Raloxifene Hydrochloride generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene Hydrochloride	RALOXIFENE HYDROCHLORIDE	NorthStar Rx LLC	0f7d1f81-374f-4ad5-aea0-2f97abbe1dbf	2024-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Raloxifene Hydrochloride generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene Hydrochloride	RALOXIFENE HYDROCHLORIDE	Aurobindo Pharma Limited	e8b6cbe0-c1f4-4678-b852-f629a7f6a1b5	2024-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Raloxifene Hydrochloride generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene hydrochloride	RALOXIFENE HYDROCHLORIDE	A-S Medication Solutions	22a951ee-2ffc-4c60-b681-0f80285153e1	2023-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Raloxifene hydrochloride generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene Hydrochloride	RALOXIFENE HYDROCHLORIDE	Bryant Ranch Prepack	3568ed3c-6afd-4872-a861-93a7873bec9c	2023-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Raloxifene Hydrochloride generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene hydrochloride	RALOXIFENE HYDROCHLORIDE	Bryant Ranch Prepack	ad3ef791-ac90-4f66-8da6-95b31e4c3eb6	2023-03-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Raloxifene hydrochloride generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene hydrochloride	RALOXIFENE HYDROCHLORIDE	ScieGen Pharmaceuticals Inc	8152e68b-61a8-4897-8e03-900135b1dbd5	2023-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Raloxifene hydrochloride generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene hydrochloride	RALOXIFENE HYDROCHLORIDE	Dr.Reddys Laboratories Inc	8f24455c-34dc-4e07-bcd3-24326b9cc377	2022-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Raloxifene hydrochloride generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene hydrochloride	RALOXIFENE HYDROCHLORIDE	Cadila Pharmaceuticals Limited	a46bcc4f-f63d-4200-836d-a653a3c616db	2022-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Raloxifene hydrochloride generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene hydrochloride	RALOXIFENE HYDROCHLORIDE	Modavar Pharmaceuticals LLC	f0db29f5-28da-4165-94f8-24727b6b71e5	2022-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Raloxifene hydrochloride generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene Hydrochloride	RALOXIFENE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	e6be5b1d-757d-4bab-ad6a-c421960a104d	2021-08-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Raloxifene Hydrochloride generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene Hydrochloride	RALOXIFENE	Aphena Pharma Solutions - Tennessee, LLC	53a2db10-4af8-4032-b598-b7c7a0969801	2021-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Raloxifene Hydrochloride

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.