Application 075797

Type: ANDA
Sponsor: MAYNE 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	Yes

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
A075797-001	TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20
A075797-002	TAMOXIFEN CITRATE	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	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
A075797-001	AB
A075797-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075797-001	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	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075797-001	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	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075797-001	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	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075797-001	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	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075797-001	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	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075797-001	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	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075797-001	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	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075797-001	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	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075797-001	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	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075797-001	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	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075797-001	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	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2003-02-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075797-001	TAMOXIFEN CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2003-02-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075797-002	TAMOXIFEN CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	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	A075797-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075797-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075797-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075797-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075797-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075797-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075797-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075797-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075797-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075797-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075797-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075797-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075797-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075797-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075797-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075797-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075797-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075797-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075797-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075797-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075797-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075797-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075797-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075797-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075797-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075797-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075797-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075797-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075797-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075797-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075797-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075797-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075797-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075797-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075797-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075797-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075797-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075797-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075797-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075797-002	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tamoxifen Citrate	TAMOXIFEN CITRATE	Mayne Pharma Commercial LLC	c82205a3-ae0c-4ce5-b04b-9581cd8c70d4	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075797 application number: ANDA075797 ndc (product): 51862-642 ndc (product): 51862-643
Tamoxifen Citrate	TAMOXIFEN CITRATE	Dr. Reddy's Labratories Inc.	c6c6a643-57d6-7ea5-7da0-e8a66802468a	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075797 application number: ANDA075797

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0179-0224	Tamoxifen Citrate	Tamoxifen Citrate	KAISER FOUNDATION HOSPITALS	ANDA	Current
51407-439	Tamoxifen Citrate	Tamoxifen Citrate	Golden State Medical Supply, Inc.	ANDA	Current
51407-439	Tamoxifen Citrate	Tamoxifen Citrate	Golden State Medical Supply, Inc.	ANDA	Current
51407-439	Tamoxifen Citrate	Tamoxifen Citrate	Golden State Medical Supply, Inc.	ANDA	Current
51407-440	Tamoxifen Citrate	Tamoxifen Citrate	Golden State Medical Supply, Inc.	ANDA	Current
51407-440	Tamoxifen Citrate	Tamoxifen Citrate	Golden State Medical Supply, Inc.	ANDA	Current
51407-440	Tamoxifen Citrate	Tamoxifen Citrate	Golden State Medical Supply, Inc.	ANDA	Current
51862-446	Tamoxifen Citrate	Tamoxifen Citrate	Mayne Pharma Inc.	ANDA	Current
51862-446	Tamoxifen Citrate	Tamoxifen Citrate	Mayne Pharma Inc.	ANDA	Current
51862-446	Tamoxifen Citrate	Tamoxifen Citrate	Mayne Pharma Inc.	ANDA	Current
51862-446	Tamoxifen Citrate	Tamoxifen Citrate	Mayne Pharma Inc.	ANDA	Current
51862-446	Tamoxifen Citrate	Tamoxifen Citrate	Mayne Pharma Inc.	ANDA	Current
51862-447	Tamoxifen Citrate	Tamoxifen Citrate	Mayne Pharma Inc.	ANDA	Current
51862-447	Tamoxifen Citrate	Tamoxifen Citrate	Mayne Pharma Inc.	ANDA	Current
51862-447	Tamoxifen Citrate	Tamoxifen Citrate	Mayne Pharma Inc.	ANDA	Current
51862-447	Tamoxifen Citrate	Tamoxifen Citrate	Mayne Pharma Inc.	ANDA	Current
51862-642	Tamoxifen Citrate	Tamoxifen Citrate	Mayne Pharma Inc.	ANDA	Current
51862-642	Tamoxifen Citrate	Tamoxifen Citrate	Mayne Pharma Inc.	ANDA	Current
51862-643	Tamoxifen Citrate	Tamoxifen Citrate	Mayne Pharma Inc.	ANDA	Current
51862-643	Tamoxifen Citrate	Tamoxifen Citrate	Mayne Pharma Inc.	ANDA	Current
60429-909	Tamoxifen Citrate	Tamoxifen Citrate	Golden State Medical Supply, Inc.	ANDA	Current
60429-909	Tamoxifen Citrate	Tamoxifen Citrate	Golden State Medical Supply, Inc.	ANDA	Current
60429-909	Tamoxifen Citrate	Tamoxifen Citrate	Golden State Medical Supply, Inc.	ANDA	Current
60429-909	Tamoxifen Citrate	Tamoxifen Citrate	Golden State Medical Supply, Inc.	ANDA	Current
60429-909	Tamoxifen Citrate	Tamoxifen Citrate	Golden State Medical Supply, Inc.	ANDA	Current
60429-910	Tamoxifen Citrate	Tamoxifen Citrate	Golden State Medical Supply, Inc.	ANDA	Current
60429-910	Tamoxifen Citrate	Tamoxifen Citrate	Golden State Medical Supply, Inc.	ANDA	Current
60429-910	Tamoxifen Citrate	Tamoxifen Citrate	Golden State Medical Supply, Inc.	ANDA	Current
60429-910	Tamoxifen Citrate	Tamoxifen Citrate	Golden State Medical Supply, Inc.	ANDA	Current
60429-910	Tamoxifen Citrate	Tamoxifen Citrate	Golden State Medical Supply, Inc.	ANDA	Current
63739-143	Tamoxifen Citrate	Tamoxifen Citrate	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-143	Tamoxifen Citrate	Tamoxifen Citrate	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-143	Tamoxifen Citrate	Tamoxifen Citrate	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-269	Tamoxifen Citrate	Tamoxifen Citrate	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-269	Tamoxifen Citrate	Tamoxifen Citrate	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-269	Tamoxifen Citrate	Tamoxifen Citrate	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-269	Tamoxifen Citrate	Tamoxifen Citrate	McKesson Corporation dba SKY Packaging	ANDA	Current
65084-269	Tamoxifen Citrate	Tamoxifen Citrate	McKesson Corporation dba RX Pak	ANDA	Current
71335-0237	Tamoxifen Citrate	Tamoxifen Citrate	Bryant Ranch Prepack	ANDA	Current
71335-0237	Tamoxifen Citrate	Tamoxifen Citrate	Bryant Ranch Prepack	ANDA	Current
71335-0237	Tamoxifen Citrate	Tamoxifen Citrate	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8794	ORIG	2004-06-18