Application 208524

Type: NDA
Sponsor: EISAI INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BELVIQ XR	LORCASERIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	20MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog.

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	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208524-001	BELVIQ XR	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-07-15	`74a2ff9319b5…`
2021-03-12 10:30 UTC	2021-03	N208524-001	BELVIQ XR	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-07-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208524-001	BELVIQ XR	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-07-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208524-001	BELVIQ XR	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-07-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208524-001	BELVIQ XR	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-07-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208524-001	BELVIQ XR	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-07-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208524-001	BELVIQ XR	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-07-15	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 305 observed states.

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	N208524-001	6953787	2023-04-10	U-1254	Drug substance, Drug product	2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	6953787	2023-04-10	U-1255	Drug substance, Drug product	2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	6953787	2023-04-10	U-1253	Drug substance, Drug product	2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	6953787	2023-04-10	U-1252	Drug substance, Drug product	2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	7514422	2023-04-10	U-1254		2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	7514422	2023-04-10	U-1255		2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	7514422	2023-04-10	U-1252		2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	7514422	2023-04-10	U-1253		2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	7977329	2023-04-10	U-1254	Drug substance, Drug product	2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	7977329	2023-04-10	U-1252	Drug substance, Drug product	2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	7977329	2023-04-10	U-1253	Drug substance, Drug product	2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	7977329	2023-04-10	U-1255	Drug substance, Drug product	2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	8207158	2023-04-10	U-1254		2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	8207158	2023-04-10	U-1255		2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	8207158	2023-04-10	U-1252		2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	8207158	2023-04-10	U-1253		2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	8273734	2023-04-10	U-1254		2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	8273734	2023-04-10	U-1255		2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	8367657	2023-04-10	U-1252	Drug substance, Drug product	2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	8367657	2023-04-10	U-1254	Drug substance, Drug product	2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	8367657	2023-04-10	U-1253	Drug substance, Drug product	2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	8367657	2023-04-10	U-1255	Drug substance, Drug product	2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	8546379	2023-04-10	U-1252	Drug substance, Drug product	2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	8546379	2023-04-10	U-1255	Drug substance, Drug product	2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	8546379	2023-04-10	U-1254	Drug substance, Drug product	2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	8546379	2023-04-10	U-1253	Drug substance, Drug product	2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	8575149	2023-04-10	U-1452		2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	8946207	2024-06-16		Drug product	2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	8697686	2025-12-20		Drug substance, Drug product	2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	8980881	2025-12-20	U-1254		2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	8980881	2025-12-20	U-1255		2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	8980881	2025-12-20	U-1253		2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	8980881	2025-12-20	U-1252		2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	8168624	2029-04-18		Drug substance, Drug product	2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	10226471	2031-08-31		Drug product	2019-04-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	9770455	2031-08-31	U-2110		2017-09-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	9169213	2032-12-06	U-1885		2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	9169213	2032-12-06	U-1887		2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	9169213	2032-12-06	U-1884		2016-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208524-001	9169213	2032-12-06	U-1886		2016-08-12	`74a2ff9319b5…`

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62856-535	BELVIQ XR	lorcaserin hydrochloride hemihydrate	Eisai Inc.	NDA	Current
62856-535	BELVIQ XR	lorcaserin hydrochloride hemihydrate	Eisai Inc.	NDA	Current
62856-535	BELVIQ XR	lorcaserin hydrochloride hemihydrate	Eisai Inc.	NDA	Current
62856-535	BELVIQ XR	lorcaserin hydrochloride hemihydrate	Eisai Inc.	NDA	Current
62856-535	BELVIQ XR	lorcaserin hydrochloride hemihydrate	Eisai Inc.	NDA	Current
62856-535	BELVIQ XR	lorcaserin hydrochloride hemihydrate	Eisai Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48545	SUPPL	2017-05-26
48530	SUPPL	2017-05-25
46039	ORIG	2016-10-26
46038	ORIG	2016-10-26
32911	ORIG	2016-07-19
40636	ORIG	2016-07-18