Application 009435

Type: NDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NESACAINE	CHLOROPROCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1%	Yes	Yes
002	NESACAINE	CHLOROPROCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	2%	Yes	No
003	NESACAINE-MPF	CHLOROPROCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	2%	No	No
004	NESACAINE-MPF	CHLOROPROCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	3%	No	No
006	NESACAINE-MPF	CHLOROPROCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	2%	Yes	Yes
007	NESACAINE-MPF	CHLOROPROCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	3%	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N009435-001	NESACAINE	CHLOROPROCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION		RLD, Approved before 1982
N009435-002	NESACAINE	CHLOROPROCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982
N009435-003	NESACAINE-MPF	CHLOROPROCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION		Approved before 1982
N009435-004	NESACAINE-MPF	CHLOROPROCAINE HYDROCHLORIDE	3%	INJECTABLE / INJECTION		Approved before 1982
N009435-006	NESACAINE-MPF	CHLOROPROCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02
N009435-007	NESACAINE-MPF	CHLOROPROCAINE HYDROCHLORIDE	3%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N009435-002	AP
N009435-006	AP
N009435-007	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 7 · 252 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
2026-08-18 06:07:40	2026-07	N009435-001	NESACAINE	1%	INJECTABLE / INJECTION		RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009435-002	NESACAINE	2%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009435-003	NESACAINE-MPF	2%	INJECTABLE / INJECTION		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009435-004	NESACAINE-MPF	3%	INJECTABLE / INJECTION		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009435-006	NESACAINE-MPF	2%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009435-007	NESACAINE-MPF	3%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N009435-001	NESACAINE	1%	INJECTABLE / INJECTION		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009435-002	NESACAINE	2%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009435-003	NESACAINE-MPF	2%	INJECTABLE / INJECTION		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009435-004	NESACAINE-MPF	3%	INJECTABLE / INJECTION		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009435-006	NESACAINE-MPF	2%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009435-007	NESACAINE-MPF	3%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009435-001	NESACAINE	1%	INJECTABLE / INJECTION		RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009435-002	NESACAINE	2%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009435-003	NESACAINE-MPF	2%	INJECTABLE / INJECTION		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009435-004	NESACAINE-MPF	3%	INJECTABLE / INJECTION		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009435-006	NESACAINE-MPF	2%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009435-007	NESACAINE-MPF	3%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009435-001	NESACAINE	1%	INJECTABLE / INJECTION		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009435-002	NESACAINE	2%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009435-003	NESACAINE-MPF	2%	INJECTABLE / INJECTION		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009435-004	NESACAINE-MPF	3%	INJECTABLE / INJECTION		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009435-006	NESACAINE-MPF	2%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009435-007	NESACAINE-MPF	3%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009435-001	NESACAINE	1%	INJECTABLE / INJECTION		RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009435-002	NESACAINE	2%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009435-003	NESACAINE-MPF	2%	INJECTABLE / INJECTION		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009435-004	NESACAINE-MPF	3%	INJECTABLE / INJECTION		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009435-006	NESACAINE-MPF	2%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009435-007	NESACAINE-MPF	3%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009435-001	NESACAINE	1%	INJECTABLE / INJECTION		RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009435-002	NESACAINE	2%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009435-003	NESACAINE-MPF	2%	INJECTABLE / INJECTION		Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009435-004	NESACAINE-MPF	3%	INJECTABLE / INJECTION		Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009435-006	NESACAINE-MPF	2%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009435-007	NESACAINE-MPF	3%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009435-001	NESACAINE	1%	INJECTABLE / INJECTION		RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009435-002	NESACAINE	2%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009435-003	NESACAINE-MPF	2%	INJECTABLE / INJECTION		Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009435-004	NESACAINE-MPF	3%	INJECTABLE / INJECTION		Approved before 1982		`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	N009435-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009435-006	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009435-007	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N009435-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009435-006	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009435-007	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009435-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009435-006	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009435-007	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009435-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009435-006	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009435-007	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009435-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009435-006	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009435-007	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009435-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009435-006	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009435-007	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009435-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009435-006	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009435-007	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009435-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009435-006	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009435-007	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009435-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009435-006	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009435-007	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009435-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009435-006	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009435-007	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N009435-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N009435-006	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N009435-007	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009435-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009435-006	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009435-007	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009435-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009435-006	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009435-007	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009435-002	AP	1	`1e350fbaab3a…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
(CHLOROPROCAINE HCI	(CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	94d13f48-fbca-67b4-e053-2995a90a791b	2024-01-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 009435 application number: NDA009435 ndc (product): 51662-1407
CHLOROPROCAINE HCI	CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	9611d194-b6dd-93f4-e053-2a95a90a1816	2024-01-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 009435 application number: NDA009435 ndc (product): 51662-1408
CHLOROPROCAINE HCI	CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	94d13f48-fbc6-67b4-e053-2995a90a791b	2024-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 009435 application number: NDA009435 ndc (product): 51662-1401
Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	a844e68a-1462-40e4-be5e-f56214906eb9	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 009435 application number: NDA009435 ndc (product): 63323-478 ndc (product): 63323-477 ndc (product): 63323-476 ndc (product): 63323-475

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9926	Nesacaine	Chloroprocaine Hydrochloride	Henry Schein, Inc.	NDA	Current
0404-9926	Nesacaine	Chloroprocaine Hydrochloride	Henry Schein, Inc.	NDA	Current
0404-9927	NESACAINE	chloroprocaine hydrochloride	Henry Schein, Inc.	NDA	Current
0404-9927	NESACAINE	chloroprocaine hydrochloride	Henry Schein, Inc.	NDA	Current
51662-1401	CHLOROPROCAINE HCI	CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1401	CHLOROPROCAINE HCI	CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1401	CHLOROPROCAINE HCI	CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1407	(CHLOROPROCAINE HCI	(CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1407	(CHLOROPROCAINE HCI	(CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1407	(CHLOROPROCAINE HCI	(CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1408	CHLOROPROCAINE HCI	CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1408	CHLOROPROCAINE HCI	CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1408	CHLOROPROCAINE HCI	CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1408	CHLOROPROCAINE HCI	CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
52584-475	Nesacaine	Chloroprocaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-475	Nesacaine	Chloroprocaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-475	Nesacaine	Chloroprocaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-475	Nesacaine	Chloroprocaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-475	Nesacaine	Chloroprocaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-475	Nesacaine	Chloroprocaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-476	NESACAINE	chloroprocaine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-476	NESACAINE	chloroprocaine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-476	NESACAINE	chloroprocaine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-476	NESACAINE	chloroprocaine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-476	NESACAINE	chloroprocaine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-476	NESACAINE	chloroprocaine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-476	NESACAINE	chloroprocaine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
63323-475	Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-475	Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-475	Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-476	Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-476	Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-476	Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-477	Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-477	Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-477	Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-478	Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-478	Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-478	Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56313	SUPPL	2018-11-06
56257	SUPPL	2018-11-05
11879	SUPPL	2010-03-18
192	SUPPL	2010-03-18
33004	SUPPL	2010-02-25
10729	SUPPL	2010-02-25
11878	SUPPL	2004-06-23
33003	SUPPL	2004-06-22