Application 207183

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.25%	No	No
002	BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.5%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A207183-001	BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP		2016-05-13
A207183-002	BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP		2016-05-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207183-001	AP
A207183-002	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 1 of 3 · 84 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
2026-08-18 06:07:40	2026-07	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207183-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207183-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207183-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207183-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207183-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207183-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207183-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207183-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207183-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207183-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207183-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207183-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207183-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207183-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207183-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207183-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207183-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207183-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207183-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207183-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207183-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207183-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207183-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207183-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207183-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207183-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207183-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207183-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207183-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207183-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207183-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207183-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207183-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207183-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207183-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207183-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207183-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207183-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207183-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207183-002	AP	1	`bb7c543d1eb4…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Eugia US LLC	ffecf450-1f01-4721-8e10-251385852612	2025-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207183 application number: ANDA207183 ndc (product): 55150-250 ndc (product): 55150-249
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	A-S Medication Solutions	1091d4d8-5dad-46e1-8f26-7bc0c5dd833f	2024-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207183 application number: ANDA207183 ndc (product): 50090-4516
BUPIVACAINE HCI	BUPIVACAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	e37e1599-db88-2fcd-e053-2995a90a00e5	2024-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207183 application number: ANDA207183 ndc (product): 51662-1581
BUPIVACAINE HYDROCHLORIDE injection, solution	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION	HF Acquisition Co LLC, DBA HealthFirst	06c15208-c600-7173-e063-6394a90a2f94	2024-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207183 application number: ANDA207183
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	694926ac-aff0-aa1f-e053-2991aa0a9588	2023-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207183 application number: ANDA207183 ndc (product): 71872-7133
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	d1642239-4230-b679-e053-2a95a90a3b7c	2023-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207183 application number: ANDA207183 ndc (product): 71872-7270

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4516	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4516	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	A-S Medication Solutions	ANDA	Current
51662-1581	BUPIVACAINE HCI	BUPIVACAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
55150-249	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-249	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-249	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-250	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-250	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-250	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
70529-006	Burapren 0.5%	Bupivacaine Hydrochloride	IT3 Medical LLC	ANDA	Current
70529-006	Burapren 0.5%	Bupivacaine Hydrochloride	IT3 Medical LLC	ANDA	Current
70529-006	Burapren 0.5%	Bupivacaine Hydrochloride	IT3 Medical LLC	ANDA	Current
71872-7133	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7133	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7270	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current