Application 204310

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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 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
A204310-001	RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB		2015-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204310-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204310-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204310-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204310-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204310-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204310-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204310-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204310-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204310-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204310-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204310-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204310-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204310-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204310-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204310-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204310-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204310-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204310-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204310-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204310-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204310-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204310-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204310-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204310-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204310-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204310-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204310-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204310-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204310-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204310-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204310-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204310-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204310-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204310-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204310-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204310-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204310-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204310-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204310-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204310-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204310-001	AB	1	`e64feba35796…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Raloxifene Hydrochloride	RALOXIFENE HYDROCHLORIDE	A-S Medication Solutions	804e873e-f48b-4c25-ad7b-41d44f61bdde	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204310 application number: ANDA204310
Raloxifene Hydrochloride	RALOXIFENE HYDROCHLORIDE	Bryant Ranch Prepack	5a22ae27-1c55-487b-8e93-8ef1cec87065	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204310 application number: ANDA204310 ndc (product): 71335-2059
Raloxifene Hydrochloride	RALOXIFENE HYDROCHLORIDE	NorthStar Rx LLC	0f7d1f81-374f-4ad5-aea0-2f97abbe1dbf	2024-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204310 application number: ANDA204310 ndc (product): 16714-213
Raloxifene Hydrochloride	RALOXIFENE HYDROCHLORIDE	Aurobindo Pharma Limited	e8b6cbe0-c1f4-4678-b852-f629a7f6a1b5	2024-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204310 application number: ANDA204310 ndc (product): 65862-709

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-213	Raloxifene Hydrochloride	Raloxifene Hydrochloride	NorthStar Rx LLC	ANDA	Current
43353-253	Raloxifene Hydrochloride	Raloxifene Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
52343-137	Raloxifene Hydrochloride	Raloxifene Hydrochloride	ACETRIS HEALTH, LLC	ANDA	Current
52343-137	Raloxifene Hydrochloride	Raloxifene Hydrochloride	LUCID PHARMA LLC	ANDA	Current
65862-709	Raloxifene Hydrochloride	Raloxifene Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-709	Raloxifene Hydrochloride	Raloxifene Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-709	Raloxifene Hydrochloride	Raloxifene Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
66993-661	Raloxifene Hydrochloride	Raloxifene Hydrochloride	Prasco Laboratories	ANDA	Current
66993-661	Raloxifene Hydrochloride	Raloxifene Hydrochloride	Prasco Laboratories	ANDA	Current
66993-661	Raloxifene Hydrochloride	Raloxifene Hydrochloride	Prasco Laboratories	ANDA	Current
71335-2059	Raloxifene Hydrochloride	Raloxifene Hydrochloride	Bryant Ranch Prepack	ANDA	Current