Application 213186

Type: ANDA
Sponsor: GRANULES 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
A213186-001	RAMELTEON	RAMELTEON	8MG	TABLET / ORAL			2020-08-21

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	A213186-001	RAMELTEON	8MG	TABLET / ORAL		2020-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213186-001	RAMELTEON	8MG	TABLET / ORAL		2020-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213186-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-08-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213186-001	RAMELTEON	8MG	TABLET / ORAL		2020-08-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A213186-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213186-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213186-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213186-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213186-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213186-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213186-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213186-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213186-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213186-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213186-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213186-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213186-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213186-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213186-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213186-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213186-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213186-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213186-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213186-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213186-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213186-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213186-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213186-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213186-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213186-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213186-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213186-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213186-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213186-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213186-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213186-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213186-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213186-001	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
Ramelteon	RAMELTEON	AvKARE	b6fc0db5-c68f-5af9-e053-2a95a90a5110	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213186 application number: ANDA213186 ndc (product): 42291-776
Ramelteon	RAMELTEON	Bryant Ranch Prepack	af1db3bf-1c7c-441e-8497-7c35f45fb00e	2024-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213186 application number: ANDA213186 ndc (product): 63629-8531
Ramelteon	RAMELTEON	Granules Pharmaceuticals Inc.	a0a57843-81cb-474d-8e90-e04bbe93216a	2023-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213186 application number: ANDA213186 ndc (product): 70010-028
Ramelteon	RAMELTEON	Proficient Rx LP	7ca849d3-f0ba-45b5-9aec-f4b7ea105fac	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213186 application number: ANDA213186 ndc (product): 71205-918

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-776	Ramelteon	Ramelteon	AvKARE	ANDA	Current
42291-776	Ramelteon	Ramelteon	AvKARE	ANDA	Current
63629-8531	Ramelteon	Ramelteon	Bryant Ranch Prepack	ANDA	Current
63629-8531	Ramelteon	Ramelteon	Bryant Ranch Prepack	ANDA	Current
63629-8531	Ramelteon	Ramelteon	Bryant Ranch Prepack	ANDA	Current
70010-028	Ramelteon	Ramelteon	Granules Pharmaceuticals Inc.	ANDA	Current
70010-028	Ramelteon	Ramelteon	Granules Pharmaceuticals Inc.	ANDA	Current
70010-028	Ramelteon	Ramelteon	Granules Pharmaceuticals Inc.	ANDA	Current
70010-028	Ramelteon	Ramelteon	Granules Pharmaceuticals Inc.	ANDA	Current
71205-918	Ramelteon	Ramelteon	Proficient Rx LP	ANDA	Current
71205-918	Ramelteon	Ramelteon	Proficient Rx LP	ANDA	Current