Application 213074

Type: ANDA
Sponsor: CAPLIN

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
A213074-001	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-04-20
A213074-002	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213074-001	AP
A213074-002	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 · 66 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	A213074-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213074-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213074-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213074-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213074-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213074-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213074-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213074-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213074-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213074-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213074-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213074-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213074-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213074-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213074-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213074-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213074-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213074-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213074-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213074-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213074-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213074-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213074-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213074-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213074-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213074-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213074-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213074-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213074-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213074-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213074-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213074-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213074-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213074-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213074-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213074-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213074-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213074-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213074-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213074-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-20	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 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	A213074-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213074-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213074-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213074-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213074-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213074-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213074-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213074-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213074-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213074-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213074-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213074-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213074-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213074-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213074-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213074-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213074-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213074-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213074-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213074-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213074-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213074-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213074-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213074-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213074-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213074-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213074-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213074-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213074-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213074-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213074-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213074-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213074-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213074-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213074-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213074-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213074-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213074-002	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213074-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213074-002	AP	1	`6a51e52b5d6a…`

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	Medical Purchasing Solutions, LLC	ea6027ca-aac5-c33a-e053-2995a90a87fc	2023-05-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213074 application number: ANDA213074 ndc (product): 71872-7271
Neostigmine Methylsulfate	NEOSTIGMINE METHYLSULFATE	Somerset Therapeutics, LLC	ea767851-b0ab-4a4c-a4b2-680ff4086636	2021-10-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213074 application number: ANDA213074 ndc (product): 70069-806 ndc (product): 70069-805
Neostigmine Methylsulfate	NEOSTIGMINE METHYLSULFATE	Xellia Pharmaceuticals USA LLC	398d8193-e1e8-42b5-a95a-86cde967c7d0	2021-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213074 application number: ANDA213074 ndc (product): 70594-072 ndc (product): 70594-069
Neostigmine Methylsulfate	NEOSTIGMINE METHYLSULFATE	Caplin Steriles Limited	11f38ea2-be55-4119-8eee-776f84c5e7f8	2021-04-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213074 application number: ANDA213074 ndc (product): 65145-111 ndc (product): 65145-112

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65145-111	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Caplin Steriles Limited	ANDA	Current
65145-112	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Caplin Steriles Limited	ANDA	Current
70069-805	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Somerset Therapeutics, LLC	ANDA	Current
70069-806	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Somerset Therapeutics, LLC	ANDA	Current
70594-069	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Xellia Pharmaceuticals USA LLC	ANDA	Current
70594-072	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Xellia Pharmaceuticals USA LLC	ANDA	Current
71872-7271	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Medical Purchasing Solutions, LLC	ANDA	Current