Application 020866

Type: NDA
Sponsor: VEROSCIENCE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYCLOSET	BROMOCRIPTINE MESYLATE	TABLET;ORAL	EQ 0.8MG BASE	Yes	Yes

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
N020866-001	CYCLOSET	BROMOCRIPTINE MESYLATE	EQ 0.8MG BASE	TABLET / ORAL		RLD, RS	2009-05-05

Orange Book patents#

Current patent rows page 1 of 2 · 126 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N020866-001	10688155	2030-06-07	U-2281		2020-08-18
N020866-001	10688155	2030-06-07	U-2890		2020-08-18
N020866-001	10688155	2030-06-07	U-2891		2020-08-18
N020866-001	10688155	2030-06-07	U-2892		2020-08-18
N020866-001	10688155	2030-06-07	U-2893		2020-08-18
N020866-001	10688155	2030-06-07	U-2894		2020-08-18
N020866-001	10688155	2030-06-07	U-2895		2020-08-18
N020866-001	10688155	2030-06-07	U-2896		2020-08-18
N020866-001	10688155	2030-06-07	U-2897		2020-08-18
N020866-001	10688155	2030-06-07	U-2898		2020-08-18
N020866-001	10688155	2030-06-07	U-2899		2020-08-18
N020866-001	10688155	2030-06-07	U-2900		2020-08-18
N020866-001	10688155	2030-06-07	U-2901		2020-08-18
N020866-001	10688155	2030-06-07	U-2902		2020-08-18
N020866-001	10688155	2030-06-07	U-2903		2020-08-18
N020866-001	10688155	2030-06-07	U-2904		2020-08-18
N020866-001	10688155	2030-06-07	U-2905		2020-08-18
N020866-001	10688155	2030-06-07	U-2906		2020-08-18
N020866-001	10688155	2030-06-07	U-2907		2020-08-18
N020866-001	10688155	2030-06-07	U-2908		2020-08-18
N020866-001	10688155	2030-06-07	U-2909		2020-08-18
N020866-001	10688155	2030-06-07	U-2910		2020-08-18
N020866-001	10688155	2030-06-07	U-2911		2020-08-18
N020866-001	10688155	2030-06-07	U-2912		2020-08-18
N020866-001	10688155	2030-06-07	U-2913		2020-08-18
N020866-001	10688155	2030-06-07	U-2914		2020-08-18
N020866-001	10688155	2030-06-07	U-2915		2020-08-18
N020866-001	10688155	2030-06-07	U-2916		2020-08-18
N020866-001	10688155	2030-06-07	U-2917		2020-08-18
N020866-001	10688155	2030-06-07	U-2918		2020-08-18
N020866-001	10688155	2030-06-07	U-2919		2020-08-18
N020866-001	10688155	2030-06-07	U-2920		2020-08-18
N020866-001	10688155	2030-06-07	U-2921		2020-08-18
N020866-001	10688155	2030-06-07	U-2922		2020-08-18
N020866-001	10688155	2030-06-07	U-2923		2020-08-18
N020866-001	10688155	2030-06-07	U-2924		2020-08-18
N020866-001	10688155	2030-06-07	U-2925		2020-08-18
N020866-001	10688155	2030-06-07	U-2926		2020-08-18
N020866-001	10688155	2030-06-07	U-2927		2020-08-18
N020866-001	10688155	2030-06-07	U-2928		2020-08-18
N020866-001	10688155	2030-06-07	U-2929		2020-08-18
N020866-001	10688155	2030-06-07	U-2930		2020-08-18
N020866-001	10688155	2030-06-07	U-2931		2020-08-18
N020866-001	10688155	2030-06-07	U-2932		2020-08-18
N020866-001	10688155	2030-06-07	U-2933		2020-08-18
N020866-001	10688155	2030-06-07	U-2934		2020-08-18
N020866-001	10688155	2030-06-07	U-2935		2020-08-18
N020866-001	10688155	2030-06-07	U-2936		2020-08-18
N020866-001	10688155	2030-06-07	U-2937		2020-08-18
N020866-001	8877708	2030-06-07	U-1706	Drug product	2015-06-18
N020866-001	9352025	2030-06-07	U-2111		2017-09-27
N020866-001	9352025	2030-06-07	U-2112		2017-09-27
N020866-001	9352025	2030-06-07	U-2113		2017-09-27
N020866-001	9352025	2030-06-07	U-2114		2017-09-27
N020866-001	9352025	2030-06-07	U-2115		2017-09-27
N020866-001	9352025	2030-06-07	U-2116		2017-09-27
N020866-001	9352025	2030-06-07	U-2117		2017-09-27
N020866-001	9352025	2030-06-07	U-2118		2017-09-27
N020866-001	9352025	2030-06-07	U-2119		2017-09-27
N020866-001	9895422	2030-06-07	U-2114		2018-05-07
N020866-001	9895422	2030-06-07	U-2116		2018-05-07
N020866-001	9895422	2030-06-07	U-2281		2018-05-07
N020866-001	9895422	2030-06-07	U-2282		2018-05-07
N020866-001	9895422	2030-06-07	U-2283		2018-05-07
N020866-001	9895422	2030-06-07	U-2284		2018-05-07
N020866-001	9895422	2030-06-07	U-2285		2018-05-07
N020866-001	9895422	2030-06-07	U-2286		2018-05-07
N020866-001	9895422	2030-06-07	U-2287		2018-05-07
N020866-001	10688094	2032-04-30	U-2870		2020-08-11
N020866-001	10688094	2032-04-30	U-2871		2020-08-11
N020866-001	10688094	2032-04-30	U-2872		2020-08-11
N020866-001	10688094	2032-04-30	U-2873		2020-08-11
N020866-001	10688094	2032-04-30	U-2874		2020-08-11
N020866-001	10688094	2032-04-30	U-2875		2020-08-11
N020866-001	10688094	2032-04-30	U-2876		2020-08-11
N020866-001	10688094	2032-04-30	U-2877		2020-08-11
N020866-001	10688094	2032-04-30	U-2878		2020-08-11
N020866-001	10688094	2032-04-30	U-2879		2020-08-11
N020866-001	10688094	2032-04-30	U-2880		2020-08-11
N020866-001	10688094	2032-04-30	U-2881		2020-08-11

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N020866-001	CYCLOSET	EQ 0.8MG BASE	TABLET / ORAL	RLD, RS	2009-05-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020866-001	CYCLOSET	EQ 0.8MG BASE	TABLET / ORAL	RLD, RS	2009-05-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020866-001	CYCLOSET	EQ 0.8MG BASE	TABLET / ORAL	RLD, RS	2009-05-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020866-001	CYCLOSET	EQ 0.8MG BASE	TABLET / ORAL	RLD, RS	2009-05-05	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 131 · 5,208 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2898	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2905	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2902	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2890	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2914	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2911	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2903	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2281	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2901	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2912	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2891	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2896	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2893	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2899	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2904	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2900	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2906	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2908	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2913	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2894	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2910	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2892	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2895	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2909	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2897	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2907	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2936	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2915	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2935	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2932	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2924	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2926	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2931	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2927	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2918	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2933	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2916	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2920	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2922	2020-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020866-001	10688155	2030-06-07	U-2921	2020-08-18	`c2088c7a36db…`

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
CYCLOSET	BROMOCRIPTINE MESYLATE	Avvisto Therapeutics LLC	e42ba916-16b9-4d1c-8d09-9d2fbb1b6c20	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020866 application number: NDA020866

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68012-258	CYCLOSET	bromocriptine mesylate	Santarus, Inc.	NDA	Current
68012-258	CYCLOSET	bromocriptine mesylate	Santarus, Inc.	NDA	Current
68012-258	CYCLOSET	bromocriptine mesylate	Santarus, Inc.	NDA	Current
68012-258	CYCLOSET	bromocriptine mesylate	Santarus, Inc.	NDA	Current
68012-258	CYCLOSET	bromocriptine mesylate	Santarus, Inc.	NDA	Current
68012-258	CYCLOSET	bromocriptine mesylate	Santarus, Inc.	NDA	Current
68012-258	CYCLOSET	bromocriptine mesylate	Santarus, Inc.	NDA	Current
68012-258	CYCLOSET	bromocriptine mesylate	Santarus, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64295	SUPPL	2020-08-18
64291	SUPPL	2020-08-18
62624	SUPPL	2020-04-22
62450	SUPPL	2020-04-06
47123	SUPPL	2017-02-07
47122	SUPPL	2017-02-07
47121	SUPPL	2017-02-07
47120	SUPPL	2017-02-07
13645	SUPPL	2016-02-11
3616	SUPPL	2016-02-04
13644	SUPPL	2015-10-22
3615	SUPPL	2015-10-21
24182	ORIG	2011-10-03
21032	ORIG	2011-10-03
35535	SUPPL	2011-03-28
3614	SUPPL	2011-03-28