Application 211324

Type: ANDA
Sponsor: CADILA PHARMS 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
A211324-001	RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB		2020-08-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211324-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211324-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2020-08-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211324-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211324-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211324-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211324-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211324-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211324-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211324-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211324-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211324-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211324-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211324-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211324-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211324-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211324-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211324-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211324-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211324-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211324-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211324-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211324-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211324-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211324-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211324-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211324-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211324-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211324-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211324-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211324-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211324-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211324-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211324-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211324-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211324-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211324-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211324-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211324-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211324-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211324-001	AB	1	`a50c72e98297…`

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	Bryant Ranch Prepack	7e4bfee5-fefc-4115-9bdb-222eccefca83	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211324 application number: ANDA211324
Raloxifene hydrochloride	RALOXIFENE HYDROCHLORIDE	A-S Medication Solutions	22a951ee-2ffc-4c60-b681-0f80285153e1	2023-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211324 application number: ANDA211324 ndc (product): 50090-6177
Raloxifene hydrochloride	RALOXIFENE HYDROCHLORIDE	Cadila Pharmaceuticals Limited	a46bcc4f-f63d-4200-836d-a653a3c616db	2022-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211324 application number: ANDA211324 ndc (product): 71209-082
Raloxifene hydrochloride	RALOXIFENE HYDROCHLORIDE	Modavar Pharmaceuticals LLC	f0db29f5-28da-4165-94f8-24727b6b71e5	2022-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211324 application number: ANDA211324 ndc (product): 72241-010

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
50090-6177	Raloxifene hydrochloride	Raloxifene hydrochloride	A-S Medication Solutions	ANDA	Current
50090-6177	Raloxifene hydrochloride	Raloxifene hydrochloride	A-S Medication Solutions	ANDA	Current
71209-082	Raloxifene hydrochloride	Raloxifene hydrochloride	Cadila Pharmaceuticals Limited	ANDA	Current
71209-082	Raloxifene hydrochloride	Raloxifene hydrochloride	Cadila Pharmaceuticals Limited	ANDA	Current
72241-010	Raloxifene hydrochloride	Raloxifene hydrochloride	Modavar Pharmaceuticals LLC	ANDA	Current