Application 214348

Type: ANDA
Sponsor: HENGRUI PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUPIVACAINE LIPOSOME	BUPIVACAINE	INJECTABLE, LIPOSOMAL;INJECTION	133MG/10ML (13.3MG/ML)	No	No
002	BUPIVACAINE LIPOSOME	BUPIVACAINE	INJECTABLE, LIPOSOMAL;INJECTION	266MG/20ML (13.3MG/ML)	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214348-001	BUPIVACAINE LIPOSOME	BUPIVACAINE	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION			2024-07-01
A214348-002	BUPIVACAINE LIPOSOME	BUPIVACAINE	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION			2024-07-01

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214348-001	BUPIVACAINE LIPOSOME	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		2024-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214348-002	BUPIVACAINE LIPOSOME	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		2024-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214348-001	BUPIVACAINE LIPOSOME	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		2024-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214348-002	BUPIVACAINE LIPOSOME	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		2024-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214348-001	BUPIVACAINE LIPOSOME	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	2024-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214348-002	BUPIVACAINE LIPOSOME	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	2024-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214348-001	BUPIVACAINE LIPOSOME	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	2024-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214348-002	BUPIVACAINE LIPOSOME	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	2024-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214348-001	BUPIVACAINE LIPOSOME	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	2024-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214348-002	BUPIVACAINE LIPOSOME	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	2024-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214348-001	BUPIVACAINE LIPOSOME	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	2024-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214348-002	BUPIVACAINE LIPOSOME	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	2024-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214348-001	BUPIVACAINE LIPOSOME	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	2024-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214348-002	BUPIVACAINE LIPOSOME	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	2024-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214348-001	BUPIVACAINE LIPOSOME	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	2024-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214348-002	BUPIVACAINE LIPOSOME	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	2024-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214348-001	BUPIVACAINE LIPOSOME	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	2024-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214348-002	BUPIVACAINE LIPOSOME	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	2024-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214348-001	BUPIVACAINE LIPOSOME	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	2024-07-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214348-002	BUPIVACAINE LIPOSOME	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	2024-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214348-001	BUPIVACAINE LIPOSOME	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	2024-07-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214348-002	BUPIVACAINE LIPOSOME	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	2024-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214348-001	BUPIVACAINE LIPOSOME	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	2024-07-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214348-002	BUPIVACAINE LIPOSOME	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	2024-07-01	`301d65b070ca…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214348-001	BUPIVACAINE LIPOSOME	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		2024-07-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214348-002	BUPIVACAINE LIPOSOME	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		2024-07-01	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A214348-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214348-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214348-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214348-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214348-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214348-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214348-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214348-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214348-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214348-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214348-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214348-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214348-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214348-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214348-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214348-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214348-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214348-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214348-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214348-002	AP	1	`301d65b070ca…`

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	BUPIVACAINE	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	0af296bb-1599-4b35-b66b-994924d3e898	2024-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214348 application number: ANDA214348

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79301	ORIG	2024-08-02