Application 208797

Type: ANDA
Sponsor: INVATECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	SYRUP;ORAL	60MG/5ML	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
A208797-001	PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA		2020-01-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208797-001	AA

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.

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	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208797-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208797-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208797-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208797-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208797-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208797-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208797-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208797-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208797-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208797-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208797-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208797-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208797-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208797-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208797-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208797-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208797-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208797-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208797-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208797-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208797-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208797-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208797-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208797-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208797-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208797-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208797-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208797-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208797-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208797-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208797-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208797-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208797-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208797-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208797-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208797-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208797-001	AA	1	`a50c72e98297…`

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
PRYIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	Apnar Pharma LP	d42f2d2e-b9f8-7c22-e053-2995a90a9661	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208797 application number: ANDA208797 ndc (product): 24689-104
Pryidostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Rising Pharma Holdings, Inc.	beda905e-005a-439d-ac74-92db4e269780	2022-09-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208797 application number: ANDA208797 ndc (product): 16571-833

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
13811-716	Pryidostigmine Bromide	Pyridostigmine Bromide	Trigen Laboratories LLC	ANDA	Current
13811-716	Pryidostigmine Bromide	Pyridostigmine Bromide	Trigen Laboratories LLC	ANDA	Current
16571-833	Pryidostigmine Bromide	Pyridostigmine Bromide	Rising Pharma Holdings, Inc.	ANDA	Current
24689-104	PRYIDOSTIGMINE BROMIDE	pyridostigmine bromide	Apnar Pharma LP	ANDA	Current
73152-028	Pryidostigmine Bromide	Pyridostigmine Bromide	Athem LLC	ANDA	Current