Application 017697

Type: NDA
Sponsor: BRACCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KINEVAC	SINCALIDE	INJECTABLE;INJECTION	0.005MG/VIAL	Yes	Yes

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

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
N017697-001	KINEVAC	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017697-001	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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017697-001	KINEVAC	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N017697-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017697-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017697-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017697-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017697-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017697-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017697-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017697-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017697-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017697-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017697-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017697-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017697-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017697-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017697-001	AP	1	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017697-001	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017697-001	6803046	2022-08-16	Drug product	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017697-001	6803046	2022-08-16	Drug product	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017697-001	6803046	2022-08-16	Drug product	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017697-001	6803046	2022-08-16	Drug product	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017697-001	6803046	2022-08-16	Drug product	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017697-001	6803046	2022-08-16	Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017697-001	6803046	2022-08-16	Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017697-001	6803046	2022-08-16	Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017697-001	6803046	2022-08-16	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017697-001	6803046	2022-08-16	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017697-001	6803046	2022-08-16	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017697-001	6803046	2022-08-16	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017697-001	6803046	2022-08-16	Drug product	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N017697-001	6803046	2022-08-16	Drug product	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017697-001	6803046	2022-08-16	Drug product	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017697-001	6803046	2022-08-16	Drug product	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017697-001	6803046	2022-08-16	Drug product	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017697-001	6803046	2022-08-16	Drug product	`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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SINCALIDE	SINCALIDE	Fresenius Kabi USA, LLC	bb5057da-8568-49b9-947d-fab7d8d8f257	2024-01-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017697 application number: NDA017697
KINEVAC	SINCALIDE	Bracco Diagnostics Inc.	1408aabb-6982-48e5-ae9f-504ec43b0003	2023-10-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017697 application number: NDA017697 ndc (product): 0270-0556

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0270-0556	KINEVAC	sincalide	Bracco Diagnostics Inc.	NDA	Current
0270-0556	KINEVAC	sincalide	Bracco Diagnostics Inc.	NDA	Current
0270-0556	KINEVAC	sincalide	Bracco Diagnostics Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75874	SUPPL	2023-10-20
75835	SUPPL	2023-10-18
56926	SUPPL	2018-12-21
56788	SUPPL	2018-12-19
54303	SUPPL	2018-05-22
54301	SUPPL	2018-05-22
53145	SUPPL	2018-03-22
53143	SUPPL	2018-03-22
52628	SUPPL	2018-02-14
52551	SUPPL	2018-02-09
40755	SUPPL	2012-11-09
20086	SUPPL	2012-11-09
20085	SUPPL	2012-11-09
20084	SUPPL	2012-11-09
13885	SUPPL	2005-04-28
13884	SUPPL	2004-06-07
691	SUPPL	2004-06-07
690	SUPPL	2004-06-07
689	SUPPL	2004-06-07