Application 211567

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RAMELTEON	RAMELTEON	TABLET;ORAL	8MG	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
A211567-001	RAMELTEON	RAMELTEON	8MG	TABLET / ORAL	AB		2019-07-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211567-001	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.

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	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211567-001	RAMELTEON	8MG	TABLET / ORAL	AB	2019-07-22	`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	A211567-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211567-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211567-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211567-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211567-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211567-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211567-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211567-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211567-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211567-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211567-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211567-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211567-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211567-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211567-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211567-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211567-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211567-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211567-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211567-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211567-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211567-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211567-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211567-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211567-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211567-001	AB	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211567-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211567-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211567-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211567-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211567-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211567-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211567-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211567-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211567-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211567-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211567-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211567-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211567-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211567-001	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ramelteon	RAMELTEON	Major Pharmaceuticals	44be28b2-f079-40ce-b86d-8b60eda1a7c0	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211567 application number: ANDA211567
RAMELTEON	RAMELTEON	DIRECT RX	b336438f-7951-d3b7-e053-2995a90a4d69	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211567 application number: ANDA211567 ndc (product): 72189-153
Ramelteon	RAMELTEON	Zydus Lifesciences Limited	14ba7994-476a-4978-8cac-29989335a63c	2024-12-04		Exact identifier application applno (ANDA): 211567 application number: ANDA211567 ndc (product): 70771-1495
Ramelteon	RAMELTEON	American Health Packaging	094d5aa0-aa29-4898-928a-fe0d283a5271	2024-07-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211567 application number: ANDA211567
Ramelteon	RAMELTEON	Asclemed USA, Inc.	208dbac2-2634-4aff-8e2c-e5ecb47145e2	2023-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211567 application number: ANDA211567
Ramelteon	RAMELTEON	Bryant Ranch Prepack	bccc4f11-6081-49a1-9abd-2f4c2d69b380	2023-11-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211567 application number: ANDA211567 ndc (product): 71335-1853
Ramelteon	RAMELTEON	Zydus Pharmaceuticals USA Inc.	5db0e3ff-fefb-4c54-b9f9-b555e482e147	2023-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211567 application number: ANDA211567 ndc (product): 70710-1344

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70710-1344	Ramelteon	Ramelteon	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1344	Ramelteon	Ramelteon	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1344	Ramelteon	Ramelteon	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1495	Ramelteon	Ramelteon	Cadila Healthcare Limited	ANDA	Current
70771-1495	Ramelteon	Ramelteon	Zydus Lifesciences Limited	ANDA	Current
70771-1495	Ramelteon	Ramelteon	Cadila Healthcare Limited	ANDA	Current
71335-1853	Ramelteon	Ramelteon	Bryant Ranch Prepack	ANDA	Current
72189-153	RAMELTEON	RAMELTEON	DIRECT RX	ANDA	Current