Application 085882

Type: ANDA
Sponsor: CHARTWELL RX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	DUVOID	BETHANECHOL CHLORIDE	TABLET;ORAL	50MG	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
A085882-003	DUVOID	BETHANECHOL CHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A085882-003	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.

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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085882-003	DUVOID	50MG	TABLET / ORAL	AA	Approved before 1982	`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	A085882-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085882-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085882-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085882-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085882-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085882-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085882-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085882-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085882-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085882-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085882-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085882-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085882-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085882-003	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085882-003	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085882-003	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085882-003	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085882-003	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085882-003	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085882-003	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085882-003	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085882-003	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085882-003	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085882-003	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085882-003	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085882-003	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085882-003	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085882-003	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085882-003	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085882-003	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085882-003	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085882-003	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085882-003	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085882-003	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085882-003	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085882-003	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085882-003	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085882-003	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085882-003	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085882-003	AA	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 · 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