Application 070929

Type: ANDA
Sponsor: ACTAVIS LABS FL INC

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
A070929-001	TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20
A070929-002	TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB		2003-02-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070929-001	AB
A070929-002	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 3 · 82 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	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070929-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2003-02-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A070929-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2003-02-20	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A070929-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070929-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070929-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070929-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070929-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070929-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070929-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070929-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070929-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070929-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070929-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070929-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070929-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070929-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070929-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070929-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070929-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070929-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070929-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070929-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070929-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070929-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070929-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070929-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070929-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070929-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070929-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A070929-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070929-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070929-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070929-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A070929-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070929-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A070929-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070929-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A070929-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070929-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A070929-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070929-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A070929-002	AB	1	`782e0a99824c…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tamoxifen Citrate	TAMOXIFEN CITRATE	Bryant Ranch Prepack	8c0eb763-420a-4106-ba56-526b53a7f72b	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070929 application number: ANDA070929
Tamoxifen Citrate	TAMOXIFEN CITRATE	A-S Medication Solutions	8d731e7e-3b04-49a2-a0f6-3779422174cc	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070929 application number: ANDA070929 ndc (product): 50090-0485
Tamoxifen Citrate	TAMOXIFEN CITRATE	Actavis Pharma, Inc.	9b8a4211-120f-4981-ad69-928accb97637	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070929 application number: ANDA070929 ndc (product): 0591-2473 ndc (product): 0591-2472
Tamoxifen Citrate	TAMOXIFEN CITRATE	A-S Medication Solutions	716657e8-d809-4671-87bc-8d10ef69a071	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070929 application number: ANDA070929 ndc (product): 50090-0942
Tamoxifen Citrate	TAMOXIFEN CITRATE	NuCare Pharmaceuticals,Inc.	a5615dbb-3c5e-6ccc-e053-2995a90ab698	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070929 application number: ANDA070929 ndc (product): 68071-5254
Tamoxifen Citrate	TAMOXIFEN CITRATE	Proficient Rx LP	bb53eeb7-83fc-469e-b9e3-df5f27bfec7b	2022-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070929 application number: ANDA070929 ndc (product): 63187-976

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-2472	Tamoxifen Citrate	Tamoxifen Citrate	Actavis Pharma, Inc.	ANDA	Current
0591-2472	Tamoxifen Citrate	Tamoxifen Citrate	Actavis Pharma, Inc.	ANDA	Current
0591-2472	Tamoxifen Citrate	Tamoxifen Citrate	Actavis Pharma, Inc.	ANDA	Current
0591-2473	Tamoxifen Citrate	Tamoxifen Citrate	Actavis Pharma, Inc.	ANDA	Current
0591-2473	Tamoxifen Citrate	Tamoxifen Citrate	Actavis Pharma, Inc.	ANDA	Current
0591-2473	Tamoxifen Citrate	Tamoxifen Citrate	Actavis Pharma, Inc.	ANDA	Current
50090-0485	Tamoxifen Citrate	Tamoxifen Citrate	A-S Medication Solutions	ANDA	Current
50090-0485	Tamoxifen Citrate	Tamoxifen Citrate	A-S Medication Solutions	ANDA	Current
50090-0942	Tamoxifen Citrate	Tamoxifen Citrate	A-S Medication Solutions	ANDA	Current
50090-0942	Tamoxifen Citrate	Tamoxifen Citrate	A-S Medication Solutions	ANDA	Current
50090-0942	Tamoxifen Citrate	Tamoxifen Citrate	A-S Medication Solutions	ANDA	Current
51862-449	Tamoxifen Citrate	Tamoxifen Citrate	Mayne Pharma Inc.	ANDA	Current
51862-450	Tamoxifen Citrate	Tamoxifen Citrate	Mayne Pharma Inc.	ANDA	Current
63187-976	Tamoxifen Citrate	Tamoxifen Citrate	Proficient Rx LP	ANDA	Current
63187-976	Tamoxifen Citrate	Tamoxifen Citrate	Proficient Rx LP	ANDA	Current
63187-976	Tamoxifen Citrate	Tamoxifen Citrate	Proficient Rx LP	ANDA	Current
63187-976	Tamoxifen Citrate	Tamoxifen Citrate	Proficient Rx LP	ANDA	Current
68071-5005	Tamoxifen Citrate	Tamoxifen Citrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5005	Tamoxifen Citrate	Tamoxifen Citrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5254	Tamoxifen Citrate	Tamoxifen Citrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5254	Tamoxifen Citrate	Tamoxifen Citrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-1881	Tamoxifen Citrate	Tamoxifen Citrate	REMEDYREPACK INC.	ANDA	Current
71335-0662	Tamoxifen Citrate	Tamoxifen Citrate	Bryant Ranch Prepack	ANDA	Current