Application 016295

Type: NDA
Sponsor: BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDREA	HYDROXYUREA	CAPSULE;ORAL	500MG	Yes	Yes
002	DROXIA	HYDROXYUREA	CAPSULE;ORAL	200MG	Yes	No
003	DROXIA	HYDROXYUREA	CAPSULE;ORAL	300MG	Yes	No
004	DROXIA	HYDROXYUREA	CAPSULE;ORAL	400MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N016295-001	HYDREA	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982
N016295-002	DROXIA	HYDROXYUREA	200MG	CAPSULE / ORAL		RLD	1998-02-25
N016295-003	DROXIA	HYDROXYUREA	300MG	CAPSULE / ORAL		RLD	1998-02-25
N016295-004	DROXIA	HYDROXYUREA	400MG	CAPSULE / ORAL		RLD	1998-02-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N016295-001	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 5 · 172 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
2026-09-14 22:38:34	2026-08	N016295-001	HYDREA	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016295-002	DROXIA	200MG	CAPSULE / ORAL		RLD	1998-02-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016295-003	DROXIA	300MG	CAPSULE / ORAL		RLD	1998-02-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016295-004	DROXIA	400MG	CAPSULE / ORAL		RLD	1998-02-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016295-001	HYDREA	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016295-002	DROXIA	200MG	CAPSULE / ORAL		RLD	1998-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016295-003	DROXIA	300MG	CAPSULE / ORAL		RLD	1998-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016295-004	DROXIA	400MG	CAPSULE / ORAL		RLD	1998-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016295-001	HYDREA	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016295-002	DROXIA	200MG	CAPSULE / ORAL		RLD	1998-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016295-003	DROXIA	300MG	CAPSULE / ORAL		RLD	1998-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016295-004	DROXIA	400MG	CAPSULE / ORAL		RLD	1998-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016295-001	HYDREA	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016295-002	DROXIA	200MG	CAPSULE / ORAL		RLD	1998-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016295-003	DROXIA	300MG	CAPSULE / ORAL		RLD	1998-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016295-004	DROXIA	400MG	CAPSULE / ORAL		RLD	1998-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016295-001	HYDREA	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016295-002	DROXIA	200MG	CAPSULE / ORAL		RLD	1998-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016295-003	DROXIA	300MG	CAPSULE / ORAL		RLD	1998-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016295-004	DROXIA	400MG	CAPSULE / ORAL		RLD	1998-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016295-001	HYDREA	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016295-002	DROXIA	200MG	CAPSULE / ORAL		RLD	1998-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016295-003	DROXIA	300MG	CAPSULE / ORAL		RLD	1998-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016295-004	DROXIA	400MG	CAPSULE / ORAL		RLD	1998-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016295-001	HYDREA	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016295-002	DROXIA	200MG	CAPSULE / ORAL		RLD	1998-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016295-003	DROXIA	300MG	CAPSULE / ORAL		RLD	1998-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016295-004	DROXIA	400MG	CAPSULE / ORAL		RLD	1998-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016295-001	HYDREA	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016295-002	DROXIA	200MG	CAPSULE / ORAL		RLD	1998-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016295-003	DROXIA	300MG	CAPSULE / ORAL		RLD	1998-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016295-004	DROXIA	400MG	CAPSULE / ORAL		RLD	1998-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016295-001	HYDREA	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016295-002	DROXIA	200MG	CAPSULE / ORAL		RLD	1998-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016295-003	DROXIA	300MG	CAPSULE / ORAL		RLD	1998-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016295-004	DROXIA	400MG	CAPSULE / ORAL		RLD	1998-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016295-001	HYDREA	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016295-002	DROXIA	200MG	CAPSULE / ORAL		RLD	1998-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016295-003	DROXIA	300MG	CAPSULE / ORAL		RLD	1998-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016295-004	DROXIA	400MG	CAPSULE / ORAL		RLD	1998-02-25	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N016295-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N016295-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N016295-001	AB	1	`a50c72e98297…`

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
HYDREA	HYDROXYUREA	H2-Pharma LLC	6053c775-68de-45e4-9af9-33b18fd0e140	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016295 application number: NDA016295 ndc (product): 61269-835
DROXIA	HYDROXYUREA	H2-Pharma LLC	a9494409-3571-4a81-9ad3-15ef7cb636a2	2026-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 016295 application number: NDA016295 ndc (product): 61269-402 ndc (product): 61269-404 ndc (product): 61269-403
HYDREA	HYDROXYUREA	Waylis Therapeutics LLC	8d41152f-a98a-4abc-afdf-a909012434a0	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016295 application number: NDA016295
DROXIA	HYDROXYUREA	Waylis Therapeutics LLC	4ad13dc6-a2ab-4308-96b3-7c642c92cc23	2025-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 016295 application number: NDA016295

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0003-0830	HYDREA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0830	HYDREA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0830	HYDREA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0830	HYDREA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0830	HYDREA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-6335	DROXIA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-6335	DROXIA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-6335	DROXIA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-6335	DROXIA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-6335	DROXIA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-6335	DROXIA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-6335	DROXIA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-6336	DROXIA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-6336	DROXIA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-6336	DROXIA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-6336	DROXIA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-6336	DROXIA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-6336	DROXIA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-6336	DROXIA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-6337	DROXIA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-6337	DROXIA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-6337	DROXIA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-6337	DROXIA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-6337	DROXIA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-6337	DROXIA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-6337	DROXIA	HYDROXYUREA	E.R. Squibb & Sons, L.L.C.	NDA	Current
61269-402	DROXIA	HYDROXYUREA	H2-Pharma LLC	NDA	Current
61269-403	DROXIA	HYDROXYUREA	H2-Pharma LLC	NDA	Current
61269-404	DROXIA	HYDROXYUREA	H2-Pharma LLC	NDA	Current
61269-835	HYDREA	HYDROXYUREA	H2-Pharma LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78863	SUPPL	2024-07-01
78865	SUPPL	2024-06-24
76681	SUPPL	2023-11-29
76677	SUPPL	2023-11-29
76676	SUPPL	2023-11-29
74466	SUPPL	2023-06-09
74459	SUPPL	2023-06-08
69883	SUPPL	2022-01-18
69880	SUPPL	2022-01-14
68310	SUPPL	2021-08-06
68300	SUPPL	2021-08-06
66219	SUPPL	2021-02-16
66175	SUPPL	2021-02-10
61375	SUPPL	2019-12-23
61353	SUPPL	2019-12-19
59423	SUPPL	2019-07-23
59422	SUPPL	2019-07-23
59413	SUPPL	2019-07-23
50788	SUPPL	2017-12-20
50787	SUPPL	2017-12-20
50775	SUPPL	2017-12-19
50774	SUPPL	2017-12-19
50773	SUPPL	2017-12-19
50772	SUPPL	2017-12-19
33158	SUPPL	2016-03-28
33157	SUPPL	2016-03-28
437	SUPPL	2016-03-25
436	SUPPL	2015-07-20
435	SUPPL	2015-07-20
33156	SUPPL	2015-07-17
10881	SUPPL	2015-07-17
33155	SUPPL	2012-01-31
10880	SUPPL	2012-01-31
434	SUPPL	2012-01-30
433	SUPPL	2012-01-30
33154	SUPPL	2010-05-17
12984	SUPPL	2010-05-12
33153	SUPPL	2006-09-20
432	SUPPL	2006-09-20
40712	SUPPL	2004-04-14
10879	SUPPL	2004-04-05
431	SUPPL	2004-03-02
10878	SUPPL	2003-07-08
430	SUPPL	2003-07-06
429	SUPPL	2001-04-04