Application 213358

Type: ANDA
Sponsor: EUGIA PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	TABLET;ORAL	EQ 10MG BASE	No	No
002	TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	TABLET;ORAL	EQ 20MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213358-001	TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2020-08-14
A213358-002	TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB		2020-08-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A213358-001	AB
A213358-002	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 · 74 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
2026-02-19 14:30 UTC	2026-02	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213358-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-14	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213358-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-14	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213358-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213358-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213358-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213358-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213358-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213358-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213358-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213358-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213358-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213358-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213358-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213358-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213358-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213358-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213358-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213358-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213358-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213358-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213358-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213358-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213358-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213358-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213358-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213358-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213358-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213358-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213358-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213358-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213358-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213358-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213358-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213358-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213358-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213358-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213358-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213358-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213358-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213358-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213358-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213358-002	AB	1	`87673890dc5c…`

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
Tamoxifen Citrate	TAMOXIFEN CITRATE	NuCare Pharmaceuticals, Inc.	509f8ba3-214d-aec8-e063-6294a90af498	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213358 application number: ANDA213358
Tamoxifen Citrate	TAMOXIFEN CITRATE	Bryant Ranch Prepack	9b4a8abc-6e56-40c5-a826-1d1f3c0786e1	2024-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213358 application number: ANDA213358
Tamoxifen Citrate	TAMOXIFEN CITRATE	Bryant Ranch Prepack	feb96056-79f5-4024-ab0e-fdbb8d4ab862	2024-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213358 application number: ANDA213358
Tamoxifen Citrate	TAMOXIFEN CITRATE	Aurobindo Pharma Limited	a596c715-8e30-43c1-aba3-4fe5de6729fa	2020-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213358 application number: ANDA213358 ndc (product): 59651-300 ndc (product): 59651-299

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59651-299	Tamoxifen Citrate	Tamoxifen Citrate	Aurobindo Pharma Limited	ANDA	Current
59651-300	Tamoxifen Citrate	Tamoxifen Citrate	Aurobindo Pharma Limited	ANDA	Current