Application 205582

Type: NDA
Sponsor: SUN PHARMA GLOBAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DECITABINE	DECITABINE	POWDER;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
N205582-001	DECITABINE	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS		RLD	2014-01-28

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD	2014-01-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD	2014-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD	2014-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205582-001	DECITABINE	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-01-28	`e64feba35796…`

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
decitabine	DECITABINE	Sun Pharmaceutical Industries, Inc.	c155d6ba-9a16-406c-919e-65a149689ab9	2020-07-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205582 application number: NDA205582 ndc (product): 47335-361

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47335-361	decitabine	decitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-361	decitabine	decitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-361	decitabine	decitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-361	decitabine	decitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-361	decitabine	decitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-361	decitabine	decitabine	Sun Pharmaceutical Industries, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64619	SUPPL	2020-09-21
64591	SUPPL	2020-09-17
63314	SUPPL	2020-05-28
63262	SUPPL	2020-05-22
61778	SUPPL	2020-02-05
61773	SUPPL	2020-02-04
58843	SUPPL	2019-05-23
58839	SUPPL	2019-05-23
44923	ORIG	2014-06-27
22994	ORIG	2014-06-27
19660	ORIG	2014-01-28
10469	ORIG	2014-01-24