Application 078193

Type: ANDA
Sponsor: TEVA PHARMS USA

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
A078193-001	RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB		2014-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078193-001	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	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`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	A078193-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078193-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078193-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078193-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078193-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078193-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078193-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078193-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078193-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078193-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078193-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078193-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078193-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078193-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078193-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078193-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078193-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078193-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078193-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078193-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078193-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078193-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078193-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078193-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078193-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078193-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078193-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078193-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078193-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078193-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078193-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078193-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078193-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078193-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078193-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078193-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078193-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078193-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078193-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078193-001	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 · 2 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	3568ed3c-6afd-4872-a861-93a7873bec9c	2023-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078193 application number: ANDA078193 ndc (product): 71335-1715
Raloxifene Hydrochloride	RALOXIFENE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	e6be5b1d-757d-4bab-ad6a-c421960a104d	2021-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078193 application number: ANDA078193 ndc (product): 0093-7290

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7290	Raloxifene Hydrochloride	Raloxifene Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7290	Raloxifene Hydrochloride	Raloxifene Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7290	Raloxifene Hydrochloride	Raloxifene Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7290	Raloxifene Hydrochloride	Raloxifene Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7290	Raloxifene Hydrochloride	Raloxifene Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7290	Raloxifene Hydrochloride	Raloxifene Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7290	Raloxifene Hydrochloride	Raloxifene Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
42291-726	Raloxifene Hydrochloride	Raloxifene Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-726	Raloxifene Hydrochloride	Raloxifene Hydrochloride	AvKARE	ANDA	Current
68071-2412	Raloxifene Hydrochloride	Raloxifene Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-2994	Raloxifene Hydrochloride	Raloxifene Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-1715	Raloxifene Hydrochloride	Raloxifene Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1715	Raloxifene Hydrochloride	Raloxifene Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71610-504	Raloxifene Hydrochloride	Raloxifene Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
52769	ORIG	2018-02-28
9129	ORIG	2014-03-06