Application 021807

Type: NDA
Sponsor: FORTOVIA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SOLTAMOX	TAMOXIFEN CITRATE	SOLUTION;ORAL	EQ 20MG BASE/10ML	No	No

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

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
N021807-001	SOLTAMOX	TAMOXIFEN CITRATE	EQ 20MG BASE/10ML	SOLUTION / ORAL		RLD, RS	2005-10-29

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL		2005-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL		2005-10-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL		2005-10-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL		2005-10-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL		2005-10-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021807-001	SOLTAMOX	EQ 20MG BASE/10ML	SOLUTION / ORAL	RLD, RS	2005-10-29	`cb3db0bc1861…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SOLTAMOX	TAMOXIFEN CITRATE	Mayne Pharma	1e6ff055-590c-41e6-9530-1fdf04cdbd02	2021-11-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021807 application number: NDA021807 ndc (product): 51862-682

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51862-682	SOLTAMOX	TAMOXIFEN CITRATE	Mayne Pharma	NDA	Current
51862-682	SOLTAMOX	TAMOXIFEN CITRATE	Mayne Pharma	NDA	Current
89141-123	Soltamox	TAMOXIFEN CITRATE	Fortovia Therapeutics Inc.	NDA	Current
89141-123	Soltamox	TAMOXIFEN CITRATE	Midatech Pharma US Inc.	NDA	Current
89141-123	Soltamox	TAMOXIFEN CITRATE	Fortovia Therapeutics Inc.	NDA	Current
89141-123	Soltamox	TAMOXIFEN CITRATE	Midatech Pharma US Inc.	NDA	Current
89141-123	Soltamox	TAMOXIFEN CITRATE	Midatech Pharma US Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58260	SUPPL	2019-04-09
58259	SUPPL	2019-04-09
58258	SUPPL	2019-04-09
55745	SUPPL	2018-10-01
55619	SUPPL	2018-09-26
55618	SUPPL	2018-09-26
21824	ORIG	2007-09-10
43783	ORIG	2007-02-21
28635	ORIG	2005-11-01
16406	ORIG	2005-11-01