Application 212512

Type: ANDA
Sponsor: BE PHARMS

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
A212512-001	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP		2019-05-13
A212512-002	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2019-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212512-001	AP
A212512-002	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	A212512-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212512-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212512-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212512-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212512-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212512-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212512-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212512-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212512-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212512-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212512-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212512-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212512-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212512-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212512-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212512-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212512-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212512-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212512-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212512-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212512-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212512-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212512-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212512-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212512-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212512-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212512-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212512-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212512-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212512-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212512-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212512-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212512-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212512-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212512-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A212512-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212512-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212512-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212512-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212512-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-05-13	`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	A212512-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212512-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212512-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212512-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212512-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212512-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212512-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212512-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212512-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212512-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212512-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212512-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212512-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212512-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212512-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212512-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212512-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212512-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212512-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212512-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212512-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212512-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212512-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212512-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212512-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212512-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212512-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212512-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212512-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212512-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212512-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212512-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212512-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212512-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212512-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A212512-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212512-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212512-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212512-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212512-002	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neostigmine methylsulfate	NEOSTIGMINE METHYLSULFATE	BE Pharmaceuticals Inc.	971713db-d5ac-44c1-ada5-a56a943d79bf	2022-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212512 application number: ANDA212512 ndc (product): 71839-105 ndc (product): 71839-106
neostigmine methylsulfate	NEOSTIGMINE METHYLSULFATE	Camber Pharmaceuticals Inc.	d07ff23f-54a5-4036-8005-a3515d4e2194	2021-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212512 application number: ANDA212512 ndc (product): 31722-994 ndc (product): 31722-995

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
31722-994	neostigmine methylsulfate	neostigmine methylsulfate	Camber Pharmaceuticals Inc.	ANDA	Current
31722-994	neostigmine methylsulfate	neostigmine methylsulfate	Camber Pharmaceuticals Inc.	ANDA	Current
31722-995	neostigmine methylsulfate	neostigmine methylsulfate	Camber Pharmaceuticals Inc.	ANDA	Current
31722-995	neostigmine methylsulfate	neostigmine methylsulfate	Camber Pharmaceuticals Inc.	ANDA	Current
71839-105	Neostigmine methylsulfate	Neostigmine methylsulfate	BE Pharmaceuticals Inc.	ANDA	Current
71839-105	Neostigmine methylsulfate	Neostigmine methylsulfate	BE Pharmaceuticals Inc.	ANDA	Current
71839-105	Neostigmine methylsulfate	Neostigmine methylsulfate	BE Pharmaceuticals Inc.	ANDA	Current
71839-105	Neostigmine methylsulfate	Neostigmine methylsulfate	BE Pharmaceuticals Inc.	ANDA	Current
71839-106	Neostigmine methylsulfate	Neostigmine methylsulfate	BE Pharmaceuticals Inc.	ANDA	Current
71839-106	Neostigmine methylsulfate	Neostigmine methylsulfate	BE Pharmaceuticals Inc.	ANDA	Current
71839-106	Neostigmine methylsulfate	Neostigmine methylsulfate	BE Pharmaceuticals Inc.	ANDA	Current
71839-106	Neostigmine methylsulfate	Neostigmine methylsulfate	BE Pharmaceuticals Inc.	ANDA	Current
72572-460	neostigmine methylsulfate	neostigmine methylsulfate	Civica Inc.	ANDA	Current
72572-460	neostigmine methylsulfate	neostigmine methylsulfate	Civica Inc.	ANDA	Current
72572-460	neostigmine methylsulfate	neostigmine methylsulfate	Civica Inc.	ANDA	Current
72572-460	neostigmine methylsulfate	neostigmine methylsulfate	Civica Inc.	ANDA	Current
72572-461	neostigmine methylsulfate	neostigmine methylsulfate	Civica Inc.	ANDA	Current
72572-461	neostigmine methylsulfate	neostigmine methylsulfate	Civica Inc.	ANDA	Current
72572-461	neostigmine methylsulfate	neostigmine methylsulfate	Civica Inc.	ANDA	Current
72572-461	neostigmine methylsulfate	neostigmine methylsulfate	Civica Inc.	ANDA	Current