Application 203895

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.25%	No	No
002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.5%	No	No
003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.75%	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203895-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2013-11-05
A203895-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2013-11-05
A203895-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	2013-11-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203895-001	AP
A203895-002	AP
A203895-003	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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A203895-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2013-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203895-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2013-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203895-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2013-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203895-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2013-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203895-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2013-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203895-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2013-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203895-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2013-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203895-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2013-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203895-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2013-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203895-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2013-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203895-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2013-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203895-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2013-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203895-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2013-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203895-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2013-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203895-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2013-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203895-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2013-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203895-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2013-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203895-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2013-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203895-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2013-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203895-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2013-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203895-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2013-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203895-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2013-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203895-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2013-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203895-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2013-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203895-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2013-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203895-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2013-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203895-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2013-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203895-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2013-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203895-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2013-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203895-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2013-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203895-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2013-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203895-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2013-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203895-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2013-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203895-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2013-11-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203895-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2013-11-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203895-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2013-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203895-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2013-11-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203895-002	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	2013-11-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203895-003	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	2013-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203895-001	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	2013-11-05	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203895-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203895-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203895-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203895-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203895-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203895-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203895-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203895-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203895-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203895-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203895-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203895-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203895-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203895-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203895-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203895-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203895-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203895-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203895-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203895-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203895-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203895-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203895-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203895-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203895-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203895-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203895-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203895-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203895-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203895-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203895-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203895-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203895-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203895-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203895-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203895-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203895-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203895-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203895-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203895-001	AP	1	`8072bd15b7f6…`

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 · 3 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): 203895 application number: ANDA203895 ndc (product): 55150-167 ndc (product): 55150-170 ndc (product): 55150-172 ndc (product): 55150-169 ndc (product): 55150-168 ndc (product): 55150-171
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Asclemed USA, Inc.	a60303c2-5217-41db-855b-83fa2a749da2	2022-10-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203895 application number: ANDA203895 ndc (product): 76420-008
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Asclemed USA, Inc.	3eefbefe-78ae-4f2d-9be6-3f79eadcff86	2020-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203895 application number: ANDA203895 ndc (product): 76420-018

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55150-167	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-167	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-167	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-168	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-168	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-168	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-169	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-169	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-169	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-170	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-170	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-170	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-171	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-171	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-171	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-172	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-172	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-172	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
70518-2360	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2360	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2360	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70529-008	Burapren 0.75%	Bupivacaine Hydrochloride	IT3 Medical LLC	ANDA	Current
70529-008	Burapren 0.75%	Bupivacaine Hydrochloride	IT3 Medical LLC	ANDA	Current
70529-008	Burapren 0.75%	Bupivacaine Hydrochloride	IT3 Medical LLC	ANDA	Current
70859-041	Point Of Care LM DEP 2	Bupivacaine Hydrochloride,kenalog,Povidone-lodine	NuCare Pharmaceuticals,Inc.	ANDA	Current
70859-041	Point Of Care LM DEP 2	Bupivacaine Hydrochloride,kenalog,Povidone-lodine	NuCare Pharmaceuticals,Inc.	ANDA	Current
70859-042	Point Of Care Kit KM	Bupivacaine Hydrochloride,kenalog,Povidone-lodine	NuCare Pharmaceuticals,Inc.	ANDA	Current
70859-042	Point Of Care Kit KM	Bupivacaine Hydrochloride,kenalog,Povidone-lodine	NuCare Pharmaceuticals,Inc.	ANDA	Current
76420-008	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	Asclemed USA, Inc.	ANDA	Current
76420-008	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	Asclemed USA, Inc.	ANDA	Current
76420-018	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	Asclemed USA, Inc.	ANDA	Current