Application 021790

Type: NDA
Sponsor: OTSUKA PHARM CO LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DACOGEN	DECITABINE	INJECTABLE;INTRAVENOUS	50MG/VIAL	Yes	Yes

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

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
N021790-001	DACOGEN	DECITABINE	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-05-02

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 · 42 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
2026-08-18 06:07:40	2026-07	N021790-001	DACOGEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021790-001	DACOGEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021790-001	DACOGEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021790-001	DACOGEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021790-001	DACOGEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021790-001	DACOGEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021790-001	DACOGEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021790-001	DACOGEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021790-001	DACOGEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021790-001	DACOGEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021790-001	DACOGEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021790-001	DACOGEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021790-001	DACOGEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021790-001	DACOGEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021790-001	DACOGEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-05-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-05-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-05-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-05-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-05-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-05-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-05-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-05-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-05-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-05-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-05-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-05-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-05-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS		RLD	2006-05-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021790-001	DACOGEN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2006-05-02	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021790-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021790-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021790-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021790-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021790-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021790-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021790-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021790-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021790-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021790-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021790-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021790-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021790-001	AP	1	`ea99ee380514…`
2022-09-29 23:25 UTC	2022-09	N021790-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021790-001	AP	1	`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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Decitabine	DECITABINE	Sagent Pharmaceuticals	749f8d8c-e378-42a1-b94a-136b606dadb4	2026-08-06	Warnings, Adverse reactions	Name fallback generic name: DECITABINE
Decitabine	DECITABINE	Bryant Ranch Prepack	c731a9f0-46ee-41c3-8f89-179cab13bdd2	2026-05-06	Warnings, Adverse reactions	Name fallback generic name: DECITABINE
Decitabine	DECITABINE	Dr. Reddy's Laboratories Inc.	358764ca-4c69-d516-af0c-bf8a348d26ca	2026-03-25	Warnings, Adverse reactions	Name fallback generic name: DECITABINE
Decitabine	DECITABINE	Dr.Reddy's Laboratories Limited	4e1f4eb4-19b2-eee8-3402-bd2ccf622791	2026-03-25	Warnings, Adverse reactions	Name fallback generic name: DECITABINE
Decitabine	DECITABINE	Meitheal Pharmaceuticals Inc.	a535a235-e1d2-4520-93fe-b7dd9b047784	2025-12-15	Warnings, Adverse reactions	Name fallback generic name: DECITABINE
Decitabine	DECITABINE	BluePoint Laboratories	de303068-589e-4e0a-90ed-e60b2c1a2b56	2025-09-29	Warnings, Adverse reactions	Name fallback generic name: DECITABINE
Decitabine	DECITABINE	BluePoint Laboratories	00caa305-fef4-471b-b9c3-4bcf5fe7b244	2025-08-05	Warnings, Adverse reactions	Name fallback generic name: DECITABINE
Decitabine	DECITABINE	Meitheal Pharmaceuticals Inc.	a3771445-1c68-4883-a014-74f8793f3136	2025-07-23	Warnings, Adverse reactions	Name fallback generic name: DECITABINE
decitabine	DECITABINE	Hikma Pharmaceuticals USA Inc.	8c5d6067-16a1-43ab-9e52-a33c600a5c44	2024-12-26	Warnings, Adverse reactions	Name fallback generic name: DECITABINE
Decitabine	DECITABINE	Accord Healthcare Inc.	b46df7d7-d98e-4c7e-b1ee-e03e258781c4	2024-07-09	Warnings, Adverse reactions	Name fallback generic name: DECITABINE
Decitabine	DECITABINE	Camber Pharmaceuticals, Inc.	5662c353-05d0-4bd8-87e4-c92ec9ca861e	2024-06-26	Warnings, Adverse reactions	Name fallback generic name: DECITABINE
Decitabine	DECITABINE	Eugia US LLC	a99f92cf-88f9-469b-aa69-44831e0bd4ab	2023-07-29	Warnings, Adverse reactions	Name fallback generic name: DECITABINE
DECITABINE	DECITABINE	BluePoint Laboratories	6c6ab831-6234-4803-8a01-5c51ec3b0716	2023-05-26	Warnings, Adverse reactions	Name fallback generic name: DECITABINE
DECITABINE	DECITABINE	Nivagen Pharmaceuticals, Inc.	150537a8-10ac-422d-bf33-68b1a408e566	2022-02-28	Warnings, Adverse reactions	Name fallback generic name: DECITABINE
Decitabine	DECITABINE	Qilu Pharmaceutical Co., Ltd.	5b2dce6f-c715-47dc-971e-06244ccd7548	2021-10-18	Warnings, Adverse reactions	Name fallback generic name: DECITABINE
decitabine	DECITABINE	Gland Pharma Limited	39a26b24-e9d4-4974-9788-d025c51fc94f	2021-09-15	Warnings, Adverse reactions	Name fallback generic name: DECITABINE
Decitabine	DECITABINE	Amneal Pharmaceuticals LLC	40e7ef72-8df5-4adf-a269-4ae1c26eb6f9	2021-02-12	Warnings, Adverse reactions	Name fallback generic name: DECITABINE
Decitabine	DECITABINE	Novadoz Pharmaceuticals LLC	a1b43089-bc88-4ac6-bdee-9cc38ec30f4e	2021-01-01	Warnings, Adverse reactions	Name fallback generic name: DECITABINE
Decitabine	DECITABINE	Northstar Rx LLC	1abbe952-58bc-4dbc-b06a-fb79167bcd66	2020-08-17	Warnings, Adverse reactions	Name fallback generic name: DECITABINE
Decitabine	DECITABINE	Novadoz Pharmaceuticals LLC	ae6c4580-3a3a-4c42-903a-1565d79521f8	2020-08-01	Warnings, Adverse reactions	Name fallback generic name: DECITABINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59148-046	Dacogen	decitabine	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-046	Dacogen	decitabine	Otsuka America Pharmaceut	NDA	Current
59148-046	Dacogen	decitabine	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-046	Dacogen	decitabine	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-046	Dacogen	decitabine	Otsuka America Pharmaceutical, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80626	SUPPL	2024-12-18
80625	SUPPL	2024-12-18
63758	SUPPL	2020-06-30
63754	SUPPL	2020-06-30
61972	SUPPL	2020-02-26
57085	SUPPL	2018-12-31
57009	SUPPL	2018-12-26
56841	SUPPL	2018-12-20
56713	SUPPL	2018-12-12
16377	SUPPL	2015-09-04
37652	SUPPL	2010-03-18
28608	SUPPL	2010-03-18
42313	ORIG	2006-06-16
28607	ORIG	2006-05-05
16376	ORIG	2006-05-04
52604	ORIG	1900-01-01
52603	ORIG	1900-01-01