Application 018304

Type: NDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.25%	No	No
002	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.5%	No	No
003	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.75%	No	No
004	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	INJECTABLE;INJECTION	0.5%;0.0091MG/ML	No	No
005	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	INJECTABLE;INJECTION	0.75%;0.0091MG/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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018304-001	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982
N018304-002	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982
N018304-003	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982
N018304-004	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02
N018304-005	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N018304-001	AP
N018304-002	AP
N018304-003	AP
N018304-004	AP
N018304-005	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 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018304-001	SENSORCAINE	0.25%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018304-002	SENSORCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018304-003	SENSORCAINE	0.75%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018304-004	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018304-005	SENSORCAINE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018304-001	SENSORCAINE	0.25%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018304-002	SENSORCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018304-003	SENSORCAINE	0.75%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018304-004	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018304-005	SENSORCAINE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018304-001	SENSORCAINE	0.25%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018304-002	SENSORCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018304-003	SENSORCAINE	0.75%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018304-004	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018304-005	SENSORCAINE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018304-001	SENSORCAINE	0.25%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018304-002	SENSORCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018304-003	SENSORCAINE	0.75%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018304-004	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018304-005	SENSORCAINE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018304-001	SENSORCAINE	0.25%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018304-002	SENSORCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018304-003	SENSORCAINE	0.75%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018304-004	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018304-005	SENSORCAINE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018304-001	SENSORCAINE	0.25%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018304-002	SENSORCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018304-003	SENSORCAINE	0.75%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018304-004	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018304-005	SENSORCAINE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018304-001	SENSORCAINE	0.25%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018304-002	SENSORCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018304-003	SENSORCAINE	0.75%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018304-004	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018304-005	SENSORCAINE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018304-001	SENSORCAINE	0.25%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018304-002	SENSORCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018304-003	SENSORCAINE	0.75%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018304-004	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018304-005	SENSORCAINE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	N018304-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018304-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018304-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018304-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018304-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018304-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018304-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018304-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018304-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018304-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018304-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018304-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018304-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018304-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018304-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018304-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018304-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018304-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018304-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018304-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018304-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018304-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018304-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018304-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018304-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018304-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018304-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018304-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018304-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018304-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018304-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018304-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018304-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018304-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018304-005	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018304-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018304-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018304-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018304-004	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018304-005	AP	1	`5bbf6a4d5a75…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUPIVACAINE HCl	BUPIVACAINE HCL	HF Acquisition Co LLC, DBA HealthFirst	e391f807-7699-6d82-e053-2a95a90ab641	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018304 application number: NDA018304 ndc (product): 51662-1592 ndc (product): 51662-1588
Sensorcaine	BUPIVACAINE HYDROCHLORIDE	Henry Schein, Inc.	2046d833-2974-42fd-a29e-7fc1dc7166cc	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018304 application number: NDA018304 ndc (product): 0404-9945
Sensorcaine	BUPIVACAINE HYDROCHLORIDE	Henry Schein, Inc.	100201ad-6e4d-4e91-8b5c-621d0bf0dcc2	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018304 application number: NDA018304 ndc (product): 0404-9947
SENSORCAINE MPF	BUPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	b6bfc04a-1868-4630-9ca1-8c027af97ce3	2024-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 63323-464 ndc (product): 63323-466
SENSORCAINE MPF	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	eb6d8fee-def4-4c96-9972-695e8cea8ea8	2024-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018304 application number: NDA018304 ndc (product): 63323-464 ndc (product): 63323-460 ndc (product): 63323-467 ndc (product): 63323-465 ndc (product): 63323-466 ndc (product): 63323-462
Sensorcaine MPF	BUPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	e700eb7b-8b14-49c9-96b2-331f18776e45	2023-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 63323-464 ndc (product): 63323-466
SENSORCAINE MPF	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175	2022-08-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018304 application number: NDA018304 ndc (product): 63323-464 ndc (product): 63323-466 ndc (product): 63323-462

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9945	Sensorcaine	Bupivacaine Hydrochloride	Henry Schein, Inc.	NDA	Current
0404-9945	Sensorcaine	Bupivacaine Hydrochloride	Henry Schein, Inc.	NDA	Current
0404-9947	Sensorcaine	Bupivacaine Hydrochloride	Henry Schein, Inc.	NDA	Current
0404-9947	Sensorcaine	Bupivacaine Hydrochloride	Henry Schein, Inc.	NDA	Current
51662-1588	BUPIVACAINE HCl	BUPIVACAINE HCl	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1588	BUPIVACAINE HCl	BUPIVACAINE HCl	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1592	BUPIVACAINE HCl	BUPIVACAINE HCl	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
52584-465	Sensorcaine	Bupivacaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-465	Sensorcaine	Bupivacaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-465	Sensorcaine	Bupivacaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-465	Sensorcaine	Bupivacaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-465	Sensorcaine	Bupivacaine Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-465	Sensorcaine	Bupivacaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-467	Sensorcaine	Bupivacaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-467	Sensorcaine	Bupivacaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-467	Sensorcaine	Bupivacaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-467	Sensorcaine	Bupivacaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-467	Sensorcaine	Bupivacaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-467	Sensorcaine	Bupivacaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-467	Sensorcaine	Bupivacaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
63323-460	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-460	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-460	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-462	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-462	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-462	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-464	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-464	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-464	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-465	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-465	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-465	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-466	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-466	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-466	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-467	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-467	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-467	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
70518-1392	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	REMEDYREPACK INC.	NDA	Current
70518-2657	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71616	SUPPL	2022-07-21
71608	SUPPL	2022-07-20
56325	SUPPL	2018-11-07
56261	SUPPL	2018-11-05
14977	SUPPL	2015-07-14
897	SUPPL	2015-07-14
33474	SUPPL	2015-07-13
11202	SUPPL	2015-07-13