Application 209182

Type: ANDA
Sponsor: AM REGENT

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 42.

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
A209182-001	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS			2018-05-04
A209182-002	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS			2018-05-04

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 · 84 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
2026-08-18 06:07:40	2026-07	A209182-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209182-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209182-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209182-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209182-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209182-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209182-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209182-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209182-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209182-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209182-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209182-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209182-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209182-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209182-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209182-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209182-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209182-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209182-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209182-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209182-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209182-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209182-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209182-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209182-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209182-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209182-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209182-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209182-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209182-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209182-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209182-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		2018-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209182-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-05-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209182-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209182-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-05-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209182-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-05-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209182-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-05-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209182-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-05-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209182-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-05-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209182-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-05-04	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A209182-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209182-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209182-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209182-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209182-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209182-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209182-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209182-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209182-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209182-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209182-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209182-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209182-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209182-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209182-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209182-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209182-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209182-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209182-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209182-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209182-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209182-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209182-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209182-002	AP	1	`ea99ee380514…`

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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neostigmine Methylsulfate	NEOSTIGMINE METHYLSULFATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	9cc2bfa1-c968-4d01-8162-2ef188974164	2026-06-18	Warnings, Adverse reactions	Name fallback brand name: Neostigmine Methylsulfate generic name: NEOSTIGMINE METHYLSULFATE
Neostigmine Methylsulfate	NEOSTIGMINE METHYLSULFATE	Hikma Pharmaceuticals USA Inc.	7a9d996f-aecb-455f-95fc-1010e461d75d	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Neostigmine Methylsulfate generic name: NEOSTIGMINE METHYLSULFATE
Neostigmine methylsulfate	NEOSTIGMINE METHYLSULFATE	Gland Pharma Limited	4eab6184-1771-4c15-a127-4eb3e47affc2	2026-01-31	Warnings, Adverse reactions	Name fallback brand name: Neostigmine methylsulfate generic name: NEOSTIGMINE METHYLSULFATE
Neostigmine methylsulfate	NEOSTIGMINE METHYLSULFATE	ProPharma Distribution	3857462f-2d3c-bada-e063-6294a90a7438	2025-07-18	Warnings, Adverse reactions	Name fallback brand name: Neostigmine methylsulfate generic name: NEOSTIGMINE METHYLSULFATE
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	Indoco Remedies Limited	6657402f-1db2-411e-bf66-fca3902756c4	2025-03-18	Warnings, Adverse reactions	Name fallback brand name: NEOSTIGMINE METHYLSULFATE generic name: NEOSTIGMINE METHYLSULFATE
Neostigmine Methylsulfate	NEOSTIGMINE METHYLSULFATE	Civica, Inc.	454d54dc-b803-4519-81e8-ac7d21e6aae1	2024-12-26	Warnings, Adverse reactions	Name fallback brand name: Neostigmine Methylsulfate generic name: NEOSTIGMINE METHYLSULFATE
Neostigmine Methylsulfate	NEOSTIGMINE METHYLSULFATE	Fresenius Kabi USA, LLC	d0e11e4c-41c3-4874-b567-579db655fba3	2024-10-15	Warnings, Adverse reactions	Name fallback brand name: Neostigmine Methylsulfate generic name: NEOSTIGMINE METHYLSULFATE
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	Eugia US LLC	c5729883-88d7-40fe-8fe4-fe39204ccb30	2024-08-29	Warnings, Adverse reactions	Name fallback brand name: NEOSTIGMINE METHYLSULFATE generic name: NEOSTIGMINE METHYLSULFATE
Neostigmine methylsulfate	NEOSTIGMINE METHYLSULFATE	Amneal Pharmaceuticals LLC	856c3775-8925-4bd5-a93d-604829e73440	2024-06-30	Warnings, Adverse reactions	Name fallback brand name: Neostigmine methylsulfate generic name: NEOSTIGMINE METHYLSULFATE
Neostigmine Methylsulfate	NEOSTIGMINE METHYLSULFATE	Hikma Pharmaceuticals USA Inc.	28365ed5-8332-48ac-a93d-b165ac3c6eac	2024-04-10	Warnings, Adverse reactions	Name fallback brand name: Neostigmine Methylsulfate generic name: NEOSTIGMINE METHYLSULFATE
Neostigmine Methylsulfate	NEOSTIGMINE METHYLSULFATE	Hikma Pharmaceuticals USA Inc.	f6b466a7-817c-4cb6-ac58-1b3bbf0531df	2024-04-09	Warnings, Adverse reactions	Name fallback brand name: Neostigmine Methylsulfate generic name: NEOSTIGMINE METHYLSULFATE
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	Medical Purchasing Solutions, LLC	12f25113-bf55-cee7-e063-6294a90a9d56	2024-03-05	Warnings, Adverse reactions	Name fallback brand name: NEOSTIGMINE METHYLSULFATE generic name: NEOSTIGMINE METHYLSULFATE
Neostigmine Methylsulfate	NEOSTIGMINE METHYLSULFATE	Dr.Reddys Laboratories Inc	12575d1a-a2c2-37b2-0dcf-31e58bbc2a10	2024-02-07	Warnings, Adverse reactions	Name fallback brand name: Neostigmine Methylsulfate generic name: NEOSTIGMINE METHYLSULFATE
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	HF Acquisition Co LLC, DBA HealthFirst	c4be8467-7b7e-551d-e053-2995a90a3045	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: NEOSTIGMINE METHYLSULFATE generic name: NEOSTIGMINE METHYLSULFATE
Neostigmine Methylsulfate	NEOSTIGMINE METHYLSULFATE	Fresenius Kabi USA, LLC	088f96eb-20b8-48f8-ac83-329f75a44ce1	2024-01-22	Warnings, Adverse reactions	Name fallback brand name: Neostigmine Methylsulfate generic name: NEOSTIGMINE METHYLSULFATE
Neostigmine Methylsulfate	NEOSTIGMINE METHYLSULFATE	Fresenius Kabi USA, LLC	b0b509c3-8dc8-48cc-b7a8-16b93ad706c6	2024-01-01	Warnings, Adverse reactions	Name fallback brand name: Neostigmine Methylsulfate generic name: NEOSTIGMINE METHYLSULFATE
Bloxiverz	NEOSTIGMINE METHYLSULFATE	Exela Pharma Sciences, LLC	d2f55643-2b0d-4ef9-a9d8-b7138b314372	2023-12-31	Warnings, Adverse reactions	Name fallback generic name: NEOSTIGMINE METHYLSULFATE
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	Amphastar Pharmaceuticals, Inc.	e47a4a4c-0e7c-40b6-9950-5b3adadcac22	2023-06-01	Warnings, Adverse reactions	Name fallback brand name: NEOSTIGMINE METHYLSULFATE generic name: NEOSTIGMINE METHYLSULFATE
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	Medical Purchasing Solutions, LLC	6b541714-9850-bdbd-e053-2991aa0ab244	2023-06-01	Warnings, Adverse reactions	Name fallback brand name: NEOSTIGMINE METHYLSULFATE generic name: NEOSTIGMINE METHYLSULFATE
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	Par Health USA, LLC	673140f7-273e-4543-98b5-6b12c59f540b	2023-05-26	Warnings, Adverse reactions	Name fallback brand name: NEOSTIGMINE METHYLSULFATE generic name: NEOSTIGMINE METHYLSULFATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0517-1133	Neostigmine Methylsulfate	Neostigmine Methylsulfate	American Regent, Inc.	ANDA	Current
0517-1133	Neostigmine Methylsulfate	Neostigmine Methylsulfate	American Regent, Inc.	ANDA	Current
0517-1133	Neostigmine Methylsulfate	Neostigmine Methylsulfate	American Regent, Inc.	ANDA	Current
0517-1134	Neostigmine Methylsulfate	Neostigmine Methylsulfate	American Regent, Inc.	ANDA	Current
0517-1134	Neostigmine Methylsulfate	Neostigmine Methylsulfate	American Regent, Inc.	ANDA	Current
0517-1134	Neostigmine Methylsulfate	Neostigmine Methylsulfate	American Regent, Inc.	ANDA	Current