Application 088440

Type: ANDA
Sponsor: ODYSSEY PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	URECHOLINE	BETHANECHOL CHLORIDE	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A088440-001	URECHOLINE	BETHANECHOL CHLORIDE	10MG	TABLET / ORAL		RLD	1984-05-29

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088440-001	URECHOLINE	10MG	TABLET / ORAL	AA	RS	1984-05-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088440-001	URECHOLINE	10MG	TABLET / ORAL			1984-05-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088440-001	URECHOLINE	10MG	TABLET / ORAL			1984-05-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088440-001	URECHOLINE	10MG	TABLET / ORAL			1984-05-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088440-001	URECHOLINE	10MG	TABLET / ORAL			1984-05-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088440-001	URECHOLINE	10MG	TABLET / ORAL	AA	RS	1984-05-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088440-001	URECHOLINE	10MG	TABLET / ORAL	AA	RS	1984-05-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088440-001	URECHOLINE	10MG	TABLET / ORAL	AA	RS	1984-05-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088440-001	URECHOLINE	10MG	TABLET / ORAL		RLD	1984-05-29	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A088440-001	AA	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A088440-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088440-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088440-001	AA	1	`ea99ee380514…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bethanechol Chloride	BETHANECHOL CHLORIDE	Amneal Pharmaceuticals of New York LLC	16523451-cd3d-4c10-be06-d59a6f12ac68	2026-01-29	Adverse reactions	Name fallback generic name: BETHANECHOL CHLORIDE
Bethanechol Chloride	BETHANECHOL CHLORIDE	Upsher-Smith Laboratories, LLC	80393410-dd51-4cac-b27c-50ece00cca37	2025-12-16	Adverse reactions	Name fallback generic name: BETHANECHOL CHLORIDE
Bethanechol Chloride	BETHANECHOL CHLORIDE	Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.	11ba3d38-a61b-4b03-ba03-4ccf2e450d1f	2025-10-27	Adverse reactions	Name fallback generic name: BETHANECHOL CHLORIDE
Bethanechol Chloride	BETHANECHOL CHLORIDE	American Health Packaging	da12a817-9f34-4f26-a7dc-e0e8f9be91c3	2024-12-02	Adverse reactions	Name fallback generic name: BETHANECHOL CHLORIDE
Bethanechol Chloride	BETHANECHOL CHLORIDE	Amneal Pharmaceuticals LLC	45285692-de51-413e-8a51-7fb792eccc81	2024-10-23	Adverse reactions	Name fallback generic name: BETHANECHOL CHLORIDE
Bethanechol Chloride	BETHANECHOL CHLORIDE	Chartwell RX, LLC	89267333-ba8b-455b-a8dc-515a888463c2	2024-01-22	Adverse reactions	Name fallback generic name: BETHANECHOL CHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50111-324	Bethanechol Chloride	Bethanechol Chloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-324	Bethanechol Chloride	Bethanechol Chloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
51285-690	Urecholine	Bethanechol Chloride	Teva Women's Health, Inc.	ANDA	Current
51285-690	Urecholine	Bethanechol Chloride	Teva Women's Health, Inc.	ANDA	Current
71335-0904	Bethanechol Chloride	Bethanechol Chloride	Bryant Ranch Prepack	ANDA	Current
71335-0904	Bethanechol Chloride	Bethanechol Chloride	Bryant Ranch Prepack	ANDA	Current