Application 040502

Type: ANDA
Sponsor: IMPAX LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	TABLET;ORAL	60MG	No	No
002	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040502-001	PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB		2003-04-24
A040502-002	PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB		2022-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040502-001	AB
A040502-002	AB

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 · 69 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	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`b00525d2431f…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 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	A040502-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040502-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040502-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040502-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040502-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040502-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040502-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040502-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040502-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040502-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040502-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040502-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040502-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040502-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040502-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040502-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040502-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040502-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040502-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040502-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040502-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040502-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040502-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040502-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040502-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040502-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040502-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040502-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040502-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040502-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040502-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040502-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040502-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040502-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040502-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040502-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040502-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040502-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040502-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040502-001	AB	1	`b00525d2431f…`

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
Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Amneal Pharmaceuticals of New York LLC	0f56facf-1f0a-4ba5-876d-757b114dfa45	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040502 application number: ANDA040502 ndc (product): 0115-3511
Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	American Health Packaging	30cb0b9f-e308-4501-90c2-b17349c048b7	2025-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040502 application number: ANDA040502 ndc (product): 68084-494
Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Amneal Pharmaceuticals of New York LLC	91ca7bcf-d2cc-4cb3-bfbe-c294fd707524	2023-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040502 application number: ANDA040502 ndc (product): 0115-2134

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
0115-2134	Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-3511	Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-3511	Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-3511	Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-3511	Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Impax Generics	ANDA	Current
68084-494	Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	American Health Packaging	ANDA	Current
68084-494	Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	American Health Packaging	ANDA	Current
68084-494	Pyridostigmine Bromide	Pyridostigmine Bromide	American Health Packaging	ANDA	Current
68084-494	Pyridostigmine Bromide	Pyridostigmine Bromide	American Health Packaging	ANDA	Current