Application 203629

Type: NDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	SOLUTION;INTRAVENOUS	5MG/10ML (0.5MG/ML)	No	No
002	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	SOLUTION;INTRAVENOUS	10MG/10ML (1MG/ML)	No	No
003	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	SOLUTION;INTRAVENOUS	3MG/3ML (1MG/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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N203629-001	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08
N203629-002	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08
N203629-003	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N203629-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203629-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203629-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203629-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203629-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203629-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203629-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203629-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203629-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203629-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203629-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203629-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203629-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203629-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203629-003	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203629-003	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203629-003	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203629-003	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203629-003	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203629-003	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203629-003	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203629-003	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203629-003	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203629-003	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203629-003	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203629-003	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203629-003	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203629-003	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203629-003	AP	1	`a50c72e98297…`

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
Neostigmine Methylsulfate	NEOSTIGMINE METHYLSULFATE	Fresenius Kabi USA, LLC	d0e11e4c-41c3-4874-b567-579db655fba3	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203629 application number: NDA203629 ndc (product): 63323-415 ndc (product): 63323-413
Neostigmine Methylsulfate	NEOSTIGMINE METHYLSULFATE	Fresenius Kabi USA, LLC	088f96eb-20b8-48f8-ac83-329f75a44ce1	2024-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203629 application number: NDA203629 ndc (product): 65219-811
Neostigmine Methylsulfate	NEOSTIGMINE METHYLSULFATE	Fresenius Kabi USA, LLC	b0b509c3-8dc8-48cc-b7a8-16b93ad706c6	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203629 application number: NDA203629 ndc (product): 76045-214 ndc (product): 76045-383
Neostigmine Methylsulfate	NEOSTIGMINE METHYLSULFATE	Fresenius Kabi USA, LLC	6448229c-e650-47ba-bb00-cba3604502c5	2022-12-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203629 application number: NDA203629 ndc (product): 63323-415 ndc (product): 63323-413

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52584-415	Neostigmine Methylsulfate	Neostigmine Methylsulfate	General Injectables and Vaccines, Inc	NDA	Current
63323-413	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-413	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-413	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-413	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-413	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-413	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-415	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-415	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-415	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-415	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-415	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-415	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Fresenius Kabi USA, LLC	NDA	Current
65219-811	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-214	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-383	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-383	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-383	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-383	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-383	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Fresenius Kabi USA, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66118	SUPPL	2021-02-08
66116	SUPPL	2021-02-05
44887	ORIG	2015-07-22
22929	ORIG	2015-07-22
40316	ORIG	2015-01-29
10241	ORIG	2015-01-13