Application 211682

Type: ANDA
Sponsor: EMCURE PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	TABLET;ORAL	5MG	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
A211682-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2019-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211682-001	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	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-05-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-05-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-05-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-05-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-05-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-05-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-05-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-05-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-05-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-05-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-05-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-05-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-05-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-05-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2019-05-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-05-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-05-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2019-05-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2019-05-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2019-05-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2019-05-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2019-05-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2019-05-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2019-05-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-05-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-05-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-05-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2019-05-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2019-05-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2019-05-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-05-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-05-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-05-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-05-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-05-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-05-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211682-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-05-10	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211682-001	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211682-001	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211682-001	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211682-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211682-001	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211682-001	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211682-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211682-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211682-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211682-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211682-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211682-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211682-001	AB	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211682-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211682-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211682-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211682-001	BX	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211682-001	BX	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211682-001	BX	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211682-001	BX	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211682-001	BX	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211682-001	BX	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211682-001	BX	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211682-001	AB	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	73d715dc-868d-4194-b668-4c39ababa698	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211682 application number: ANDA211682

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
14539-653	Oxybutynin Chloride	Oxybutynin Chloride	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
14539-653	Oxybutynin Chloride	Oxybutynin Chloride	Heritage Pharma Labs, Inc	ANDA	Current
70518-2904	Oxybutynin Chloride	Oxybutynin Chloride	REMEDYREPACK INC.	ANDA	Current
70518-2904	Oxybutynin Chloride	Oxybutynin Chloride	REMEDYREPACK INC.	ANDA	Current