Application 212650

Type: ANDA
Sponsor: I3 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
A212650-001	RAMELTEON	RAMELTEON	8MG	TABLET / ORAL	AB		2020-04-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212650-001	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	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212650-001	RAMELTEON	8MG	TABLET / ORAL	BX	2020-04-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212650-001	RAMELTEON	8MG	TABLET / ORAL	BX	2020-04-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212650-001	RAMELTEON	8MG	TABLET / ORAL	AB	2020-04-10	`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	A212650-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212650-001	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212650-001	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212650-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212650-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212650-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212650-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212650-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212650-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212650-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212650-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212650-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212650-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212650-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212650-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212650-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212650-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212650-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212650-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212650-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212650-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212650-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212650-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212650-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212650-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212650-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212650-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212650-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212650-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212650-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212650-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212650-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212650-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212650-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212650-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212650-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212650-001	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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ramelteon	RAMELTEON	Bryant Ranch Prepack	b1706aa1-9332-4faf-8d0c-88edd00b15e3	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212650 application number: ANDA212650
Ramelteon	RAMELTEON	Bryant Ranch Prepack	3c14d79c-ece1-40c7-b725-eeb85d6f347a	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212650 application number: ANDA212650
Ramelteon	RAMELTEON	Proficient Rx LP	2cb1b48a-05c0-4058-8ccd-1971098b8ce1	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212650 application number: ANDA212650
Ramelteon	RAMELTEON	Direct_Rx	e55aea01-80e6-60ae-e053-2995a90a9ca2	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212650 application number: ANDA212650 ndc (product): 72189-369
Ramelteon	RAMELTEON	Advanced Rx Pharmacy of Tennessee, LLC	ed37ac7c-ab7e-57b3-e053-2995a90a5b90	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212650 application number: ANDA212650 ndc (product): 80425-0203
Ramelteon	RAMELTEON	Bryant Ranch Prepack	4d6ad234-69ae-4e33-824d-cff5d1500a86	2023-11-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212650 application number: ANDA212650 ndc (product): 71335-2186
Ramelteon	RAMELTEON	i3 Pharmaceuticals, LLC	32c52e03-4c2e-4774-9397-f1f0ee99b320	2023-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212650 application number: ANDA212650 ndc (product): 72319-005
Ramelteon	RAMELTEON	TruPharma, LLC	3d0cc378-4bc5-425c-8f41-43eb734c24d9	2023-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212650 application number: ANDA212650 ndc (product): 52817-235

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50436-3980	Ramelteon	Ramelteon	Unit Dose Services	ANDA	Current
52817-235	Ramelteon	Ramelteon	TruPharma, LLC	ANDA	Current
52817-235	Ramelteon	Ramelteon	TruPharma, LLC	ANDA	Current
55700-874	Ramelteon	Ramelteon	Quality Care Products, LLC	ANDA	Current
55700-874	Ramelteon	Ramelteon	Quality Care Products, LLC	ANDA	Current
71335-2186	Ramelteon	Ramelteon	Bryant Ranch Prepack	ANDA	Current
72189-369	Ramelteon	Ramelteon	Direct_Rx	ANDA	Current
72319-005	Ramelteon	Ramelteon	i3 Pharmaceuticals, LLC	ANDA	Current
72319-005	Ramelteon	Ramelteon	i3 Pharmaceuticals, LLC	ANDA	Current
80425-0203	Ramelteon	Ramelteon	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current