Rozerem

Product NDC: 63629-3389
11-digit product format: 636293389
Labeler code: 63629
Product ID: 63629-3389_99c210cf-70b1-4884-a022-ce97addcb810
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ramelteon
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: NDA021782
Marketing category: NDA
Marketing start: 2005-07-22
Marketing end: 0000-00-00
Substance: RAMELTEON
Active strength: 8 mg/1
Pharmacologic classes: Melatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-3389		D	Discontinued by firm	2026-10-16
excluded package	package	63629-3389	63629-3389-1	D	Discontinued by firm	2026-10-16
excluded package	package	63629-3389	63629-3389-2	D	Discontinued by firm	2026-10-16
excluded package	package	63629-3389	63629-3389-3	D	Discontinued by firm	2026-10-16
excluded package	package	63629-3389	63629-3389-4	D	Discontinued by firm	2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 60 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3389-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3389-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3389-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3389-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3389-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3389-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3389-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3389-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3389-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3389-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3389-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3389-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3389-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3389-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3389-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3389-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3389-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3389-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3389-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3389-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3389-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3389-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3389-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3389-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3389-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3389-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3389-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3389-3	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-3389-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-3389-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-3389-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-3389-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-3389-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-3389-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-3389-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-3389-3	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-3389-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-3389-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-3389-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-3389-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-3389-4	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-3389-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-3389-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-3389-3	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-3389-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-3389-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-3389-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-3389-3	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N021782-001	ROZEREM	RAMELTEON	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021782-001	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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021782-001	ROZEREM	8MG	TABLET / ORAL	AB	RLD, RS	2005-07-22	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N021782-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021782-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021782-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021782-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021782-001	6034239	2019-07-22	U-674	Drug substance, Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021782-001	10098866	2021-11-16	U-2433	Drug product	2018-11-06	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021782-001	10098866	2021-11-16	U-2433	Drug product	2018-11-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021782-001	10098866	2021-11-16	U-2433	Drug product	2018-11-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021782-001	10098866	2021-11-16	U-2433	Drug product	2018-11-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021782-001	10098866	2021-11-16	U-2433	Drug product	2018-11-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021782-001	10098866	2021-11-16	U-2433	Drug product	2018-11-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021782-001	6034239	2019-07-22	U-674	Drug substance, Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021782-001	10098866	2021-11-16	U-2433	Drug product	2018-11-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021782-001	6034239	2019-07-22	U-674	Drug substance, Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021782-001	10098866	2021-11-16	U-2433	Drug product	2018-11-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021782-001	6034239	2019-07-22	U-674	Drug substance, Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021782-001	10098866	2021-11-16	U-2433	Drug product	2018-11-06	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-3389-1	EA - Each	63629-3389	4844213c-5303-4c03-9ab1-7abb53b43b3a	1	2014-08-01
63629-3389-2	EA - Each	63629-3389	f9aaa38c-2ef3-49f2-80d3-58c604614f26	1	2014-08-01
63629-3389-3	EA - Each	63629-3389	810a3aaf-da47-4f7c-8569-adaa8c9f2f34	1	2014-08-01
63629-3389-4	EA - Each	63629-3389	ccb0196d-0044-4966-a9e4-d559ffb6459a	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
RAMELTEON	ACTIVE INGREDIENT	901AS54I69	ROZEREM (RAMELTEON) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
RAMELTEON	ACTIVE MOIETY	901AS54I69	ROZEREM (RAMELTEON) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000

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
Rozerem	RAMELTEON	Takeda Pharmaceuticals America, Inc.	9de82310-70e8-47b9-b1fc-6c6848b99455	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021782 application number: NDA021782