Application 020414

Type: NDA
Sponsor: US ARMY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	TABLET;ORAL	30MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020414-001	PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL			2003-02-05

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`cb3db0bc1861…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	Exact identifier application applno (NDA): 020414 application number: NDA020414 ndc (product): 72458-128

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72458-128	Pyridostigmine Bromide	Pyridostigmine Bromide	Surgeon General-Department of the Army (TSG-DA)	NDA	Current
72458-128	Pyridostigmine Bromide	Pyridostigmine Bromide	Surgeon General-Department of the Army (TSG-DA)	NDA	Current
72458-128	Pyridostigmine Bromide	Pyridostigmine Bromide	Surgeon General-Department of the Army (TSG-DA)	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83588	SUPPL	2025-09-30
83574	SUPPL	2025-09-29
79838	SUPPL	2024-10-08
79837	SUPPL	2024-10-08
45784	SUPPL	2016-11-02
45783	SUPPL	2016-11-02
45782	SUPPL	2016-11-02
41353	ORIG	2003-04-25
34638	ORIG	2003-02-05
24948	ORIG	2003-02-05