Application 209933

Type: ANDA
Sponsor: AMPHASTAR PHARMS INC

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

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

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
A209933-001	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP		2017-09-25
A209933-002	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2017-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209933-001	AP
A209933-002	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 · 82 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	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A209933-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209933-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209933-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209933-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209933-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209933-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209933-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209933-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209933-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209933-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209933-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209933-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209933-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209933-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209933-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209933-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209933-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209933-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209933-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209933-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209933-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209933-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209933-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209933-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209933-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209933-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209933-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209933-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209933-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209933-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209933-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209933-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209933-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209933-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209933-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209933-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209933-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209933-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209933-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209933-002	AP	1	`782e0a99824c…`

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
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	HF Acquisition Co LLC, DBA HealthFirst	c4be8467-7b7e-551d-e053-2995a90a3045	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209933 application number: ANDA209933 ndc (product): 51662-1557
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	Amphastar Pharmaceuticals, Inc.	e47a4a4c-0e7c-40b6-9950-5b3adadcac22	2023-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209933 application number: ANDA209933 ndc (product): 0548-9601 ndc (product): 0548-9602
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	Medical Purchasing Solutions, LLC	7978e3c0-6ee3-6db5-e053-2991aa0a2d33	2023-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209933 application number: ANDA209933 ndc (product): 71872-7143

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9925	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	Henry Schein, Inc.	ANDA	Current
0404-9925	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	Henry Schein, Inc.	ANDA	Current
0548-9601	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	Amphastar Pharmaceuticals, Inc.	ANDA	Current
0548-9601	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	Amphastar Pharmaceuticals, Inc.	ANDA	Current
0548-9601	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	Amphastar Pharmaceuticals, Inc.	ANDA	Current
0548-9602	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	Amphastar Pharmaceuticals, Inc.	ANDA	Current
0548-9602	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	Amphastar Pharmaceuticals, Inc.	ANDA	Current
0548-9602	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	Amphastar Pharmaceuticals, Inc.	ANDA	Current
50090-4532	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	A-S Medication Solutions	ANDA	Current
50090-4532	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	A-S Medication Solutions	ANDA	Current
51662-1557	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
52584-057	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	General Injectables and Vaccines, Inc.	ANDA	Current
52584-057	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	General Injectables and Vaccines, Inc.	ANDA	Current
52584-057	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	General Injectables and Vaccines, Inc.	ANDA	Current
52584-057	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	General Injectables and Vaccines, Inc.	ANDA	Current
52584-057	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	General Injectables and Vaccines, Inc.	ANDA	Current
71872-7143	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7143	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	Medical Purchasing Solutions, LLC	ANDA	Current