Application 209511

Type: NDA
Sponsor: INNOCOLL PHARMACEUTICALS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XARACOLL	BUPIVACAINE HCI	IMPLANT;SUBCUTANEOUS	300MG	No	No

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
N209511-001	XARACOLL	BUPIVACAINE HYDROCHLORIDE	100MG	IMPLANT / IMPLANTATION		RLD	2020-08-28

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209511-001	RE47826	2029-05-20	U-2949		2020-09-28
N209511-001	11746141	2033-01-09		Drug product	2023-09-27

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD	2020-08-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD	2020-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD	2020-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD	2020-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD	2020-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD	2020-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD	2020-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD	2020-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD	2020-08-28	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 59 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`6a51e52b5d6a…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209511-001	NP	2023-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209511-001	NP	2023-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209511-001	NP	2023-08-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N209511-001	NP	2023-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209511-001	NP	2023-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209511-001	NP	2023-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209511-001	NP	2023-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209511-001	NP	2023-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209511-001	NP	2023-08-28	`c0c555d07b60…`
2023-12-20 04:57 UTC	2023-12	N209511-001	NP	2023-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209511-001	NP	2023-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209511-001	NP	2023-08-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209511-001	NP	2023-08-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209511-001	NP	2023-08-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209511-001	NP	2023-08-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209511-001	NP	2023-08-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209511-001	NP	2023-08-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209511-001	NP	2023-08-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209511-001	NP	2023-08-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209511-001	NP	2023-08-28	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUPIVACAINE HCI	BUPIVACAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	e37e1599-db88-2fcd-e053-2995a90a00e5	2024-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPIVACAINE HCI

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51715-100	XARACOLL	Bupivacaine HCl Collagen-matrix	INNOCOLL PHARMACEUTICALS	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68163	ORIG	2021-07-22
64482	ORIG	2020-09-02
64460	ORIG	2020-09-01