Application 208843

Type: NDA
Sponsor: ADDMEDICA SAS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SIKLOS	HYDROXYUREA	TABLET;ORAL	100MG	Yes	No
002	SIKLOS	HYDROXYUREA	TABLET;ORAL	1GM	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N208843-001	SIKLOS	HYDROXYUREA	100MG	TABLET / ORAL		RLD	2017-12-21
N208843-002	SIKLOS	HYDROXYUREA	1GM	TABLET / ORAL		RLD, RS	2017-12-21

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208843-001	SIKLOS	100MG	TABLET / ORAL	RLD	2017-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208843-002	SIKLOS	1GM	TABLET / ORAL	RLD, RS	2017-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208843-001	SIKLOS	100MG	TABLET / ORAL	RLD	2017-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208843-002	SIKLOS	1GM	TABLET / ORAL	RLD, RS	2017-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208843-001	SIKLOS	100MG	TABLET / ORAL	RLD	2017-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208843-002	SIKLOS	1GM	TABLET / ORAL	RLD, RS	2017-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208843-001	SIKLOS	100MG	TABLET / ORAL	RLD	2017-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208843-002	SIKLOS	1GM	TABLET / ORAL	RLD, RS	2017-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208843-001	SIKLOS	100MG	TABLET / ORAL	RLD	2017-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208843-002	SIKLOS	1GM	TABLET / ORAL	RLD, RS	2017-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208843-001	SIKLOS	100MG	TABLET / ORAL	RLD	2017-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208843-002	SIKLOS	1GM	TABLET / ORAL	RLD, RS	2017-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208843-001	SIKLOS	100MG	TABLET / ORAL	RLD	2017-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208843-002	SIKLOS	1GM	TABLET / ORAL	RLD, RS	2017-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208843-001	SIKLOS	100MG	TABLET / ORAL	RLD	2017-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208843-002	SIKLOS	1GM	TABLET / ORAL	RLD, RS	2017-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208843-001	SIKLOS	100MG	TABLET / ORAL	RLD	2017-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208843-002	SIKLOS	1GM	TABLET / ORAL	RLD, RS	2017-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208843-001	SIKLOS	100MG	TABLET / ORAL	RLD	2017-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208843-002	SIKLOS	1GM	TABLET / ORAL	RLD, RS	2017-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208843-001	SIKLOS	100MG	TABLET / ORAL	RLD	2017-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208843-002	SIKLOS	1GM	TABLET / ORAL	RLD, RS	2017-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208843-001	SIKLOS	100MG	TABLET / ORAL	RLD	2017-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208843-002	SIKLOS	1GM	TABLET / ORAL	RLD, RS	2017-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208843-001	SIKLOS	100MG	TABLET / ORAL	RLD	2017-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208843-002	SIKLOS	1GM	TABLET / ORAL	RLD, RS	2017-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208843-001	SIKLOS	100MG	TABLET / ORAL	RLD	2017-12-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208843-002	SIKLOS	1GM	TABLET / ORAL	RLD, RS	2017-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208843-001	SIKLOS	100MG	TABLET / ORAL	RLD	2017-12-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208843-002	SIKLOS	1GM	TABLET / ORAL	RLD, RS	2017-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208843-001	SIKLOS	100MG	TABLET / ORAL	RLD	2017-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208843-002	SIKLOS	1GM	TABLET / ORAL	RLD, RS	2017-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208843-001	SIKLOS	100MG	TABLET / ORAL	RLD	2017-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208843-002	SIKLOS	1GM	TABLET / ORAL	RLD, RS	2017-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208843-001	SIKLOS	100MG	TABLET / ORAL	RLD	2017-12-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208843-002	SIKLOS	1GM	TABLET / ORAL	RLD, RS	2017-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208843-001	SIKLOS	100MG	TABLET / ORAL	RLD	2017-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208843-002	SIKLOS	1GM	TABLET / ORAL	RLD	2017-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208843-001	SIKLOS	100MG	TABLET / ORAL	RLD	2017-12-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208843-002	SIKLOS	1GM	TABLET / ORAL	RLD, RS	2017-12-21	`bb7c543d1eb4…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208843-001	ODE-177	2024-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208843-002	ODE-177	2024-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208843-001	ODE-177	2024-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208843-002	ODE-177	2024-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208843-001	ODE-177	2024-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208843-002	ODE-177	2024-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208843-001	ODE-177	2024-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208843-002	ODE-177	2024-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208843-001	ODE-177	2024-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208843-002	ODE-177	2024-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208843-001	ODE-177	2024-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208843-002	ODE-177	2024-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208843-001	ODE-177	2024-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208843-002	ODE-177	2024-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208843-001	ODE-177	2024-12-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208843-002	ODE-177	2024-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208843-001	ODE-177	2024-12-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208843-002	ODE-177	2024-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208843-001	ODE-177	2024-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208843-002	ODE-177	2024-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208843-001	ODE-177	2024-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208843-002	ODE-177	2024-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208843-001	ODE-177	2024-12-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208843-002	ODE-177	2024-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208843-001	NP	2020-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208843-001	ODE-177	2024-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208843-002	NP	2020-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208843-002	ODE-177	2024-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208843-001	ODE-177	2024-12-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208843-002	ODE-177	2024-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208843-001	ODE-177	2024-12-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208843-002	ODE-177	2024-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208843-001	ODE-177	2024-12-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208843-002	ODE-177	2024-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208843-001	ODE-177	2024-12-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208843-002	ODE-177	2024-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208843-001	NP	2020-12-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208843-001	ODE-177	2024-12-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208843-002	NP	2020-12-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208843-002	ODE-177	2024-12-21	`8869cabd3fbd…`

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
Siklos	HYDROXYUREA	Medunik	76957c0d-0f98-4376-bb06-eee651adc09d	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208843 application number: NDA208843 ndc (product): 71770-120 ndc (product): 71770-105

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71770-100	Siklos	hydroxyurea	Medunik	NDA	Current
71770-100	Siklos	hydroxyurea	Medunik	NDA	Current
71770-105	Siklos	hydroxyurea	Medunik	NDA	Current
71770-105	Siklos	hydroxyurea	Medunik	NDA	Current
71770-105	Siklos	hydroxyurea	Medunik	NDA	Current
71770-120	Siklos	hydroxyurea	Medunik	NDA	Current
71770-120	Siklos	hydroxyurea	Medunik	NDA	Current
71770-120	Siklos	hydroxyurea	Medunik	NDA	Current
71770-120	Siklos	hydroxyurea	Medunik	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81079	SUPPL	2025-02-06
76683	SUPPL	2023-11-29
76679	SUPPL	2023-11-29
76678	SUPPL	2023-11-29
69528	SUPPL	2021-12-10
69525	SUPPL	2021-12-10
69515	SUPPL	2021-12-08
58842	SUPPL	2019-05-23
58841	SUPPL	2019-05-23
58840	SUPPL	2019-05-23
58261	SUPPL	2019-04-09
56889	SUPPL	2018-12-20
54775	ORIG	2018-07-06
50925	ORIG	2017-12-27
50818	ORIG	2017-12-21
50817	ORIG	2017-12-21