Application 022529

Type: NDA
Sponsor: EISAI INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BELVIQ	LORCASERIN HYDROCHLORIDE	TABLET;ORAL	10MG	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	N022529-001	BELVIQ	10MG	TABLET / ORAL	RLD, RS	2012-06-27	`74a2ff9319b5…`
2021-03-12 10:30 UTC	2021-03	N022529-001	BELVIQ	10MG	TABLET / ORAL	RLD	2012-06-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022529-001	BELVIQ	10MG	TABLET / ORAL	RLD	2012-06-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022529-001	BELVIQ	10MG	TABLET / ORAL	RLD	2012-06-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022529-001	BELVIQ	10MG	TABLET / ORAL	RLD, RS	2012-06-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022529-001	BELVIQ	10MG	TABLET / ORAL	RLD, RS	2012-06-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022529-001	BELVIQ	10MG	TABLET / ORAL	RLD, RS	2012-06-27	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 294 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	N022529-001	6953787	2023-04-10	U-1255	Drug substance, Drug product	2012-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	6953787	2023-04-10	U-1253	Drug substance, Drug product	2012-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	6953787	2023-04-10	U-1254	Drug substance, Drug product	2012-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	6953787	2023-04-10	U-1252	Drug substance, Drug product	2012-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	7514422	2023-04-10	U-1255		2012-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	7514422	2023-04-10	U-1254		2012-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	7514422	2023-04-10	U-1252		2012-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	7514422	2023-04-10	U-1253		2012-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	7977329	2023-04-10	U-1254	Drug substance, Drug product	2012-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	7977329	2023-04-10	U-1252	Drug substance, Drug product	2012-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	7977329	2023-04-10	U-1255	Drug substance, Drug product	2012-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	7977329	2023-04-10	U-1253	Drug substance, Drug product	2012-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	8207158	2023-04-10	U-1254		2012-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	8207158	2023-04-10	U-1252		2012-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	8207158	2023-04-10	U-1255		2012-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	8207158	2023-04-10	U-1253		2012-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	8273734	2023-04-10	U-1254		2012-10-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	8273734	2023-04-10	U-1255		2012-10-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	8367657	2023-04-10	U-1254	Drug substance, Drug product	2013-03-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	8367657	2023-04-10	U-1253	Drug substance, Drug product	2013-03-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	8367657	2023-04-10	U-1252	Drug substance, Drug product	2013-03-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	8367657	2023-04-10	U-1255	Drug substance, Drug product	2013-03-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	8546379	2023-04-10	U-1252	Drug substance, Drug product	2013-10-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	8546379	2023-04-10	U-1254	Drug substance, Drug product	2013-10-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	8546379	2023-04-10	U-1253	Drug substance, Drug product	2013-10-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	8546379	2023-04-10	U-1255	Drug substance, Drug product	2013-10-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	8575149	2023-04-10	U-1452		2013-12-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	8946207	2024-06-16		Drug product	2015-03-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	8697686	2025-12-20		Drug substance, Drug product	2014-05-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	8980881	2025-12-20	U-1253		2015-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	8980881	2025-12-20	U-1252		2015-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	8980881	2025-12-20	U-1255		2015-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	8980881	2025-12-20	U-1254		2015-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	8168624	2029-04-18		Drug substance, Drug product	2012-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	9770455	2031-08-31	U-2110		2017-09-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	9169213	2032-12-06	U-1762		2015-11-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	9169213	2032-12-06	U-1764		2015-11-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	9169213	2032-12-06	U-1763		2015-11-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	9169213	2032-12-06	U-1765		2015-11-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022529-001	8999970	2033-02-07	U-1692		2015-05-07	`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
62856-529	Belviq	lorcaserin hydrochloride hemihydrate	Eisai Inc.	NDA	Current
62856-529	Belviq	lorcaserin hydrochloride hemihydrate	Eisai Inc.	NDA	Current
62856-529	Belviq	lorcaserin hydrochloride hemihydrate	Eisai Inc.	NDA	Current
62856-529	Belviq	lorcaserin hydrochloride hemihydrate	Eisai Inc.	NDA	Current
62856-529	Belviq	lorcaserin hydrochloride hemihydrate	Eisai Inc.	NDA	Current
62856-529	Belviq	lorcaserin hydrochloride hemihydrate	Eisai Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48544	SUPPL	2017-05-26
48543	SUPPL	2017-05-26
48532	SUPPL	2017-05-25
48531	SUPPL	2017-05-25
38820	SUPPL	2016-04-04
29837	SUPPL	2014-12-11
42552	ORIG	2012-08-07
38819	ORIG	2012-06-27
29836	ORIG	2012-06-27