Application 211488

Type: NDA
Sponsor: FORSEE PHARMACEUTICALS CO., LTD.

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CAMCEVI KIT	LEUPROLIDE MESYLATE	EMULSION;SUBCUTANEOUS	EQ 42 MG BASE	Yes	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
N211488-001	CAMCEVI KIT	LEUPROLIDE MESYLATE	EQ 42MG BASE	EMULSION / SUBCUTANEOUS		RLD, RS	2021-05-25

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N211488-001	10646572	2027-01-16	Drug product	2021-07-15
N211488-001	9744207	2027-01-16	Drug product	2021-07-15
N211488-001	9572857	2029-08-02	Drug product	2021-07-15
N211488-001	12133878	2037-12-18	Drug product	2024-11-12
N211488-001	11717555	2039-01-01	Drug product	2023-08-25

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
2026-02-19 14:30 UTC	2026-02	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211488-001	CAMCEVI KIT	EQ 42MG BASE	EMULSION / SUBCUTANEOUS	RLD, RS	2021-05-25	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 127 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N211488-001	10646572	2027-01-16	Drug product	2021-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211488-001	9572857	2027-01-16	Drug product	2021-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211488-001	9744207	2027-01-16	Drug product	2021-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211488-001	12133878	2037-12-18	Drug product	2024-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211488-001	11717555	2039-01-01	Drug product	2023-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211488-001	10646572	2027-01-16	Drug product	2021-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211488-001	9572857	2027-01-16	Drug product	2021-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211488-001	9744207	2027-01-16	Drug product	2021-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211488-001	12133878	2037-12-18	Drug product	2024-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211488-001	11717555	2039-01-01	Drug product	2023-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211488-001	10646572	2027-01-16	Drug product	2021-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211488-001	9572857	2027-01-16	Drug product	2021-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211488-001	9744207	2027-01-16	Drug product	2021-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211488-001	12133878	2037-12-18	Drug product	2024-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211488-001	11717555	2039-01-01	Drug product	2023-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211488-001	10646572	2027-01-16	Drug product	2021-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211488-001	9572857	2027-01-16	Drug product	2021-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211488-001	9744207	2027-01-16	Drug product	2021-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211488-001	12133878	2037-12-18	Drug product	2024-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211488-001	11717555	2039-01-01	Drug product	2023-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211488-001	10646572	2027-01-16	Drug product	2021-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211488-001	9572857	2027-01-16	Drug product	2021-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211488-001	9744207	2027-01-16	Drug product	2021-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211488-001	12133878	2037-12-18	Drug product	2024-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211488-001	11717555	2039-01-01	Drug product	2023-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211488-001	10646572	2027-01-16	Drug product	2021-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211488-001	9572857	2027-01-16	Drug product	2021-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211488-001	9744207	2027-01-16	Drug product	2021-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211488-001	12133878	2037-12-18	Drug product	2024-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211488-001	11717555	2039-01-01	Drug product	2023-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211488-001	10646572	2027-01-16	Drug product	2021-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211488-001	9572857	2027-01-16	Drug product	2021-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211488-001	9744207	2027-01-16	Drug product	2021-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211488-001	12133878	2037-12-18	Drug product	2024-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211488-001	11717555	2039-01-01	Drug product	2023-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211488-001	10646572	2027-01-16	Drug product	2021-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211488-001	9572857	2027-01-16	Drug product	2021-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211488-001	9744207	2027-01-16	Drug product	2021-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211488-001	11717555	2039-01-01	Drug product	2023-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211488-001	10646572	2027-01-16	Drug product	2021-07-15	`d8e5a09893c0…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211488-001	NP	2024-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211488-001	NP	2024-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211488-001	NP	2024-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211488-001	NP	2024-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211488-001	NP	2024-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211488-001	NP	2024-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211488-001	NP	2024-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211488-001	NP	2024-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211488-001	NP	2024-05-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211488-001	NP	2024-05-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211488-001	NP	2024-05-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211488-001	NP	2024-05-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N211488-001	NP	2024-05-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211488-001	NP	2024-05-25	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211488-001	NP	2024-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211488-001	NP	2024-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211488-001	NP	2024-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211488-001	NP	2024-05-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211488-001	NP	2024-05-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211488-001	NP	2024-05-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211488-001	NP	2024-05-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211488-001	NP	2024-05-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211488-001	NP	2024-05-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211488-001	NP	2024-05-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211488-001	NP	2024-05-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211488-001	NP	2024-05-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211488-001	NP	2024-05-25	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CAMCEVI	LEUPROLIDE	Accord BioPharma, Inc.	d7a8761a-d953-413a-e053-2a95a90a60ee	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211488 application number: NDA211488 ndc (product): 69448-014

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69448-014	CAMCEVI	LEUPROLIDE	Accord BioPharma, Inc.	NDA	Current
69448-014	CAMCEVI	LEUPROLIDE	Accord BioPharma, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85048	SUPPL	2026-02-13
85041	SUPPL	2026-02-13
83474	SUPPL	2025-09-25
83463	SUPPL	2025-09-25
81247	SUPPL	2025-02-14
81228	SUPPL	2025-02-12
81227	SUPPL	2025-02-12
77827	SUPPL	2024-03-14
77826	SUPPL	2024-03-14
69081	ORIG	2021-10-25
67654	ORIG	2021-06-02
67602	ORIG	2021-05-26