Application 203184

Type: ANDA
Sponsor: IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	TABLET, EXTENDED RELEASE;ORAL	180MG	No	No

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
A203184-001	PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL			2015-09-15

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203184-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-15	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203184-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203184-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203184-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203184-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203184-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203184-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203184-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203184-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203184-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203184-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203184-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203184-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203184-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203184-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203184-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203184-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203184-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203184-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203184-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203184-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203184-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203184-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203184-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203184-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203184-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203184-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203184-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203184-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203184-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203184-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203184-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203184-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203184-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203184-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203184-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203184-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203184-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203184-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203184-001	AB	1	`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 2 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mestinon	PYRIDOSTIGMINE BROMIDE	Bausch Health US, LLC	a851795e-b7a8-40c3-9922-5e79d3eb4d92	2020-12-02	Warnings, Adverse reactions	Name fallback generic name: PYRIDOSTIGMINE BROMIDE
Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Amneal Pharmaceuticals NY LLC	9c3a5abf-e217-4292-a305-5afd12b99e95	2019-04-16	Warnings, Adverse reactions	Name fallback brand name: Pyridostigmine Bromide generic name: PYRIDOSTIGMINE BROMIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1404	Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Impax Generics	ANDA	Current
0115-1404	Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1404	Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
68071-5032	Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5032	Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	NuCare Pharmaceuticals,Inc.	ANDA	Current