Application 212968

Type: ANDA
Sponsor: GLAND PHARMA LTD

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
A212968-001	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP		2019-10-16
A212968-002	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2019-10-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212968-001	AP
A212968-002	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 2 · 78 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	A212968-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212968-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212968-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212968-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212968-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212968-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212968-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212968-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212968-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212968-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212968-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212968-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212968-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212968-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212968-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212968-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212968-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212968-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212968-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212968-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212968-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212968-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212968-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212968-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212968-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212968-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212968-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212968-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212968-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212968-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212968-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212968-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212968-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212968-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212968-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A212968-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212968-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212968-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212968-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212968-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-16	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 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	A212968-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212968-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212968-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212968-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212968-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212968-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212968-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212968-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212968-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212968-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212968-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212968-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212968-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212968-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212968-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212968-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212968-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212968-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212968-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212968-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212968-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212968-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212968-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212968-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212968-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212968-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212968-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212968-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212968-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212968-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212968-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212968-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212968-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212968-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212968-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A212968-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212968-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212968-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212968-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212968-002	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	Gland Pharma Limited	4eab6184-1771-4c15-a127-4eb3e47affc2	2026-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212968 application number: ANDA212968 ndc (product): 68083-383 ndc (product): 68083-384
Neostigmine methylsulfate	NEOSTIGMINE METHYLSULFATE	ProPharma Distribution	3857462f-2d3c-bada-e063-6294a90a7438	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212968 application number: ANDA212968
Neostigmine methylsulfate	NEOSTIGMINE METHYLSULFATE	Xiromed LLC	801225d9-eb71-dbef-e860-4caf7a22f27f	2021-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212968 application number: ANDA212968 ndc (product): 70700-171 ndc (product): 70700-172

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5197	Neostigmine methylsulfate	Neostigmine methylsulfate	A-S Medication Solutions	ANDA	Current
68083-383	Neostigmine methylsulfate	Neostigmine methylsulfate	Gland Pharma Limited	ANDA	Current
68083-383	Neostigmine methylsulfate	Neostigmine methylsulfate	Gland Pharma Limited	ANDA	Current
68083-384	Neostigmine methylsulfate	Neostigmine methylsulfate	Gland Pharma Limited	ANDA	Current
68083-384	Neostigmine methylsulfate	Neostigmine methylsulfate	Gland Pharma Limited	ANDA	Current
70700-171	Neostigmine methylsulfate	Neostigmine methylsulfate	Xiromed LLC	ANDA	Current
70700-171	Neostigmine methylsulfate	Neostigmine methylsulfate	Xiromed LLC	ANDA	Current
70700-172	Neostigmine methylsulfate	Neostigmine methylsulfate	Xiromed LLC	ANDA	Current
70700-172	Neostigmine methylsulfate	Neostigmine methylsulfate	Xiromed LLC	ANDA	Current