Application 205650

Type: ANDA
Sponsor: ZYDUS PHARMS

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

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
A205650-001	PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB		2015-06-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205650-001	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 · 41 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	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205650-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2015-06-22	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A205650-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205650-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205650-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205650-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205650-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205650-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205650-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205650-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205650-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205650-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205650-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205650-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205650-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205650-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205650-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205650-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205650-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205650-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205650-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205650-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205650-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205650-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205650-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205650-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205650-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205650-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205650-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205650-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205650-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205650-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205650-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205650-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205650-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205650-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205650-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205650-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205650-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205650-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205650-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205650-001	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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
pyridostigmine bromide	PYRIDOSTIGMINE BROMIDE	Major Pharmaceuticals	36284496-e56e-466c-9b56-6007bb5bb699	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205650 application number: ANDA205650 ndc (product): 0904-6622
pyridostigmine bromide	PYRIDOSTIGMINE BROMIDE	Golden State Medical Supply, Inc.	235c6c04-3c09-0cf8-e063-6394a90a1846	2024-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205650 application number: ANDA205650
pyridostigmine bromide	PYRIDOSTIGMINE BROMIDE	Zydus Lifesciences Limited	ea4f753f-41a0-4f82-932c-181883d4b6d3	2023-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205650 application number: ANDA205650 ndc (product): 65841-819
pyridostigmine bromide	PYRIDOSTIGMINE BROMIDE	Zydus Pharmaceuticals (USA) Inc.	44e8c2dd-3931-4508-9fa7-5a660d6dfddb	2023-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205650 application number: ANDA205650 ndc (product): 68382-659

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
0904-6622	pyridostigmine bromide	pyridostigmine bromide	Major Pharmaceuticals	ANDA	Current
0904-6622	pyridostigmine bromide	pyridostigmine bromide	Major Pharmaceuticals	ANDA	Current
0904-6622	pyridostigmine bromide	pyridostigmine bromide	Major Pharmaceuticals	ANDA	Current
65841-819	pyridostigmine bromide	pyridostigmine bromide	Cadila Healthcare Limited	ANDA	Current
65841-819	pyridostigmine bromide	pyridostigmine bromide	Cadila Healthcare Limited	ANDA	Current
65841-819	pyridostigmine bromide	pyridostigmine bromide	Zydus Lifesciences Limited	ANDA	Current
68382-659	pyridostigmine bromide	pyridostigmine bromide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-659	pyridostigmine bromide	pyridostigmine bromide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-659	pyridostigmine bromide	pyridostigmine bromide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current