Application 210850

Type: NDA
Sponsor: MAIA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SINCALIDE	SINCALIDE	INJECTABLE;INJECTION	5MCG/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N210850-001	SINCALIDE	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2022-11-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N210850-001	AP

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210850-001	11110063	2038-04-20	U-3481	Drug product	2022-12-02
N210850-001	11110063	2038-04-20	U-3482	Drug product	2022-12-02
N210850-001	11110063	2038-04-20	U-3483	Drug product	2022-12-02
N210850-001	11318100	2038-04-20	U-3477	Drug product	2022-12-02
N210850-001	11318100	2038-04-20	U-3478	Drug product	2022-12-02
N210850-001	11318100	2038-04-20	U-3479	Drug product	2022-12-02
N210850-001	11318100	2038-04-20	U-3480	Drug product	2022-12-02
N210850-001	11737983	2038-04-20	U-3482	Drug product	2023-09-25
N210850-001	11737983	2038-04-20	U-3689	Drug product	2023-09-25

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.

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
2026-02-19 14:30 UTC	2026-02	N210850-001	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2022-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210850-001	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2022-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210850-001	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2022-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210850-001	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2022-11-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210850-001	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2022-11-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210850-001	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2022-11-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210850-001	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2022-11-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210850-001	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2022-11-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210850-001	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2022-11-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210850-001	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2022-11-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210850-001	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2022-11-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210850-001	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2022-11-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210850-001	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2022-11-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210850-001	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2022-11-22	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210850-001	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2022-11-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210850-001	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2022-11-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210850-001	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2022-11-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210850-001	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2022-11-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210850-001	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2022-11-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210850-001	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2022-11-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210850-001	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2022-11-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210850-001	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2022-11-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210850-001	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2022-11-22	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210850-001	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2022-11-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210850-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210850-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210850-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210850-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210850-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210850-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210850-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210850-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210850-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210850-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210850-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210850-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210850-001	AP	1	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210850-001	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 208 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210850-001	11110063	2038-04-20	U-3481	Drug product	2022-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210850-001	11110063	2038-04-20	U-3482	Drug product	2022-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210850-001	11110063	2038-04-20	U-3483	Drug product	2022-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210850-001	11318100	2038-04-20	U-3477	Drug product	2022-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210850-001	11318100	2038-04-20	U-3478	Drug product	2022-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210850-001	11318100	2038-04-20	U-3479	Drug product	2022-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210850-001	11318100	2038-04-20	U-3480	Drug product	2022-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210850-001	11737983	2038-04-20	U-3482	Drug product	2023-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210850-001	11737983	2038-04-20	U-3689	Drug product	2023-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210850-001	11110063	2038-04-20	U-3481	Drug product	2022-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210850-001	11110063	2038-04-20	U-3482	Drug product	2022-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210850-001	11110063	2038-04-20	U-3483	Drug product	2022-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210850-001	11318100	2038-04-20	U-3477	Drug product	2022-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210850-001	11318100	2038-04-20	U-3478	Drug product	2022-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210850-001	11318100	2038-04-20	U-3479	Drug product	2022-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210850-001	11318100	2038-04-20	U-3480	Drug product	2022-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210850-001	11737983	2038-04-20	U-3482	Drug product	2023-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210850-001	11737983	2038-04-20	U-3689	Drug product	2023-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210850-001	11110063	2038-04-20	U-3481	Drug product	2022-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210850-001	11110063	2038-04-20	U-3482	Drug product	2022-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210850-001	11110063	2038-04-20	U-3483	Drug product	2022-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210850-001	11318100	2038-04-20	U-3477	Drug product	2022-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210850-001	11318100	2038-04-20	U-3478	Drug product	2022-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210850-001	11318100	2038-04-20	U-3479	Drug product	2022-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210850-001	11318100	2038-04-20	U-3480	Drug product	2022-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210850-001	11737983	2038-04-20	U-3482	Drug product	2023-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210850-001	11737983	2038-04-20	U-3689	Drug product	2023-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210850-001	11110063	2038-04-20	U-3481	Drug product	2022-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210850-001	11110063	2038-04-20	U-3482	Drug product	2022-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210850-001	11110063	2038-04-20	U-3483	Drug product	2022-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210850-001	11318100	2038-04-20	U-3477	Drug product	2022-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210850-001	11318100	2038-04-20	U-3478	Drug product	2022-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210850-001	11318100	2038-04-20	U-3479	Drug product	2022-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210850-001	11318100	2038-04-20	U-3480	Drug product	2022-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210850-001	11737983	2038-04-20	U-3482	Drug product	2023-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210850-001	11737983	2038-04-20	U-3689	Drug product	2023-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210850-001	11110063	2038-04-20	U-3481	Drug product	2022-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210850-001	11110063	2038-04-20	U-3482	Drug product	2022-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210850-001	11110063	2038-04-20	U-3483	Drug product	2022-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210850-001	11318100	2038-04-20	U-3477	Drug product	2022-12-02	`b8a1b40f171c…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sincalide	SINCALIDE	FOSUN PHARMA USA INC	efbc189e-f5f8-0ac7-e053-2995a90a68a9	2024-05-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210850 application number: NDA210850 ndc (product): 72266-248
Sincalide	SINCALIDE	MAIA Pharmaceuticals, Inc.	4149af34-7b3d-4200-9609-ea856b1d6aab	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210850 application number: NDA210850 ndc (product): 70511-131

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70511-131	Sincalide	Sincalide	MAIA Pharmaceuticals, Inc.	NDA	Current
72266-248	Sincalide	Sincalide	FOSUN PHARMA USA INC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76384	ORIG	2023-11-06
75875	SUPPL	2023-10-20
75834	SUPPL	2023-10-18
72713	ORIG	2022-11-25
72684	ORIG	2022-11-23
52719	ORIG	2018-02-26