Application 211181

Type: ANDA
Sponsor: ELYSIUM

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
A211181-001	PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB		2018-07-20
A211181-002	PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB		2019-05-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211181-001	AB
A211181-002	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 3 · 82 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	A211181-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2018-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211181-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2019-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211181-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2018-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211181-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2019-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211181-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2018-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211181-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2019-05-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211181-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2018-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211181-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2019-05-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211181-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2018-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211181-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2019-05-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211181-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2018-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211181-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2019-05-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211181-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2018-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211181-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2019-05-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211181-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2018-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211181-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2019-05-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211181-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2018-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211181-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2019-05-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211181-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2018-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211181-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2019-05-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211181-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2018-07-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211181-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2019-05-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211181-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2018-07-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211181-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2019-05-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211181-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2018-07-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211181-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2019-05-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211181-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2018-07-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211181-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2019-05-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211181-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2018-07-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211181-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL		2019-05-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211181-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2018-07-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211181-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL		2019-05-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211181-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2018-07-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211181-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL		2019-05-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211181-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2018-07-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211181-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL		2019-05-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211181-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2018-07-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211181-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL		2019-05-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211181-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2018-07-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211181-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL		2019-05-14	`782e0a99824c…`

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	A211181-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211181-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211181-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211181-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211181-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211181-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211181-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211181-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211181-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211181-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211181-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211181-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211181-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211181-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211181-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211181-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211181-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211181-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211181-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211181-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211181-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211181-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211181-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211181-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211181-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211181-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211181-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211181-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211181-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211181-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211181-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211181-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211181-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211181-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211181-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211181-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211181-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211181-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211181-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211181-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Method Pharmaceuticals, LLC	1aa7a886-c726-cc91-e063-6294a90a1af1	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211181 application number: ANDA211181
Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Method Pharmaceuticals, LLC	e756717f-941b-42f2-ba3b-03798c005ae7	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211181 application number: ANDA211181 ndc (product): 58657-810

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
58657-810	Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Method Pharmaceuticals, LLC	ANDA	Current
58657-810	Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Method Pharmaceuticals, LLC	ANDA	Current
58657-810	Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Method Pharmaceuticals, LLC	ANDA	Current
58657-810	Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Method Pharmaceuticals, LLC	ANDA	Current
60687-502	Pyridostigmine Bromide	Pyridostigmine Bromide	American Health Packaging	ANDA	Current
60687-502	Pyridostigmine Bromide	Pyridostigmine Bromide	American Health Packaging	ANDA	Current
60687-502	Pyridostigmine Bromide	Pyridostigmine Bromide	American Health Packaging	ANDA	Current
63739-969	Pyridostigmine Bromide	Pyridostigmine Bromide	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-969	Pyridostigmine Bromide	Pyridostigmine Bromide	McKesson Corporation dba SKY Packaging	ANDA	Current
65084-999	Pyridostigmine Bromide	Pyridostigmine Bromide	McKesson Corporation dba RX Pak	ANDA	Current
71930-028	Pyridostigmine Bromide	Pyridostigmine Bromide	Eywa Pharma Inc	ANDA	Current
71930-028	Pyridostigmine Bromide	Pyridostigmine Bromide	Eywa Pharma Inc	ANDA	Current