Application 009830

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MESTINON	PYRIDOSTIGMINE BROMIDE	INJECTABLE;INJECTION	5MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N009830-001	MESTINON	PYRIDOSTIGMINE BROMIDE	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N009830-001	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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N009830-001	MESTINON	5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N009830-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N009830-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N009830-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009830-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009830-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009830-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009830-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009830-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009830-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009830-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009830-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N009830-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009830-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009830-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009830-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N009830-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N009830-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N009830-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N009830-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N009830-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N009830-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N009830-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N009830-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N009830-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N009830-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N009830-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N009830-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N009830-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N009830-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N009830-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N009830-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N009830-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N009830-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N009830-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N009830-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N009830-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N009830-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N009830-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N009830-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N009830-001	AP	1	`f41ea6bd6efb…`

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 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
pyridostigmine bromide	PYRIDOSTIGMINE BROMIDE	Major Pharmaceuticals	36284496-e56e-466c-9b56-6007bb5bb699	2026-08-04	Warnings, Adverse reactions	Name fallback generic name: PYRIDOSTIGMINE BROMIDE
Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Acella Pharmaceuticals, LLC	56999559-274e-44ea-a317-29366fdca908	2026-07-10	Warnings, Adverse reactions	Name fallback generic name: PYRIDOSTIGMINE BROMIDE
Pyridostigmine bromide	PYRIDOSTIGMINE BROMIDE	Amneal Pharmaceuticals LLC	52d6f195-165a-400b-a13b-489e94bcf0b0	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PYRIDOSTIGMINE BROMIDE
Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Method Pharmaceuticals, LLC	1aa7a886-c726-cc91-e063-6294a90a1af1	2026-02-12	Warnings, Adverse reactions	Name fallback generic name: PYRIDOSTIGMINE BROMIDE
Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Surgeon General-Department of the Army (TSG-DA)	0b296555-c32f-42db-b5f3-ea981a3dd2f8	2025-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PYRIDOSTIGMINE BROMIDE
Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	VistaPharm, LLC	9ab2ece0-7c0d-4045-a9f1-447aa97d623e	2025-11-25	Warnings, Adverse reactions	Name fallback generic name: PYRIDOSTIGMINE BROMIDE
Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Method Pharmaceuticals, LLC	e756717f-941b-42f2-ba3b-03798c005ae7	2025-10-21	Warnings, Adverse reactions	Name fallback generic name: PYRIDOSTIGMINE BROMIDE
Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Amneal Pharmaceuticals of New York LLC	0f56facf-1f0a-4ba5-876d-757b114dfa45	2025-10-16	Warnings, Adverse reactions	Name fallback generic name: PYRIDOSTIGMINE BROMIDE
Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Alvogen, Inc.	93454159-0c58-1980-34b9-4038a2260420	2025-10-09	Warnings, Adverse reactions	Name fallback generic name: PYRIDOSTIGMINE BROMIDE
Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	ANI Pharmaceuticals, Inc.	0a114d99-e50b-49fe-9e0f-ccce279ffb4f	2025-08-04	Warnings, Adverse reactions	Name fallback generic name: PYRIDOSTIGMINE BROMIDE
Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	American Health Packaging	30cb0b9f-e308-4501-90c2-b17349c048b7	2025-06-25	Warnings, Adverse reactions	Name fallback generic name: PYRIDOSTIGMINE BROMIDE
Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Rising Pharma Holdings, Inc.	f7a75639-a23a-4847-a962-c091c61947f0	2025-06-11	Warnings, Adverse reactions	Name fallback generic name: PYRIDOSTIGMINE BROMIDE
PRYIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	Apnar Pharma LP	d42f2d2e-b9f8-7c22-e053-2995a90a9661	2025-01-09	Warnings, Adverse reactions	Name fallback generic name: PYRIDOSTIGMINE BROMIDE
pyridostigmine bromide	PYRIDOSTIGMINE BROMIDE	Golden State Medical Supply, Inc.	235c6c04-3c09-0cf8-e063-6394a90a1846	2024-09-30	Warnings, Adverse reactions	Name fallback generic name: PYRIDOSTIGMINE BROMIDE
Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Amneal Pharmaceuticals of New York LLC	91ca7bcf-d2cc-4cb3-bfbe-c294fd707524	2023-12-31	Warnings, Adverse reactions	Name fallback generic name: PYRIDOSTIGMINE BROMIDE
pyridostigmine bromide	PYRIDOSTIGMINE BROMIDE	Zydus Lifesciences Limited	ea4f753f-41a0-4f82-932c-181883d4b6d3	2023-11-07	Warnings, Adverse reactions	Name fallback generic name: PYRIDOSTIGMINE BROMIDE
pyridostigmine bromide	PYRIDOSTIGMINE BROMIDE	Zydus Pharmaceuticals (USA) Inc.	44e8c2dd-3931-4508-9fa7-5a660d6dfddb	2023-11-07	Warnings, Adverse reactions	Name fallback generic name: PYRIDOSTIGMINE BROMIDE
Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Novadoz Pharmaceuticals LLC	0bed477f-b228-4f8d-a956-f192b1329ea0	2023-09-14	Warnings, Adverse reactions	Name fallback generic name: PYRIDOSTIGMINE BROMIDE
Pryidostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Rising Pharma Holdings, Inc.	beda905e-005a-439d-ac74-92db4e269780	2022-09-07	Warnings, Adverse reactions	Name fallback generic name: PYRIDOSTIGMINE BROMIDE
Regonol	PYRIDOSTIGMINE BROMIDE	Sandoz Inc	208af931-a44e-43bf-a265-8e08534dc55f	2021-04-01	Warnings, Adverse reactions	Name fallback generic name: PYRIDOSTIGMINE BROMIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10732	SUPPL	2005-06-21