Application 208216

Type: NDA
Sponsor: ACTAVIS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZACITIDINE	AZACITIDINE	POWDER;INTRAVENOUS, SUBCUTANEOUS	100MG/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N208216-001	AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP		2016-04-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N208216-001	AP

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N208216-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-04-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208216-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-04-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208216-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-04-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208216-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-04-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N208216-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208216-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208216-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208216-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208216-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208216-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208216-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208216-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208216-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208216-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208216-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208216-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208216-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208216-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208216-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208216-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208216-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208216-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208216-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208216-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208216-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208216-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208216-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208216-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208216-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208216-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208216-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208216-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208216-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208216-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208216-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208216-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208216-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208216-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208216-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208216-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208216-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208216-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208216-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208216-001	AP	1	`3a93d1ddd44b…`

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
Azacitidine	AZACITIDINE	BluePoint Laboratories	5f0f9ee3-a5b1-4a25-a34c-7f38c8433f4a	2025-05-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208216 application number: NDA208216 ndc (product): 68001-313

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-2897	Azacitidine	Azacitidine	Actavis Pharma, Inc.	NDA	Current
68001-313	Azacitidine	Azacitidine	BluePoint Laboratories	NDA	Current
68001-313	Azacitidine	Azacitidine	BluePoint Laboratories	NDA	Current
68001-313	Azacitidine	Azacitidine	BluePoint Laboratories	NDA	Current
68001-313	Azacitidine	Azacitidine	BluePoint Laboratories	NDA	Current
68001-313	Azacitidine	Azacitidine	BluePoint Laboratories	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80681	SUPPL	2024-12-23
80660	SUPPL	2024-12-20
74471	SUPPL	2023-06-09
74465	SUPPL	2023-06-09
63952	SUPPL	2020-07-17
63892	SUPPL	2020-07-14
56091	SUPPL	2018-10-24
56086	SUPPL	2018-10-23
51031	SUPPL	2018-01-11
51027	SUPPL	2018-01-11
49024	ORIG	2017-07-20
10650	ORIG	2016-05-04
40626	ORIG	2016-05-03