Home Applications 020866 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 2 of 2 · 126 matching rows.
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 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 c2088c7a36db…2026-09-14 22:38:34 2026-08 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 3a93d1ddd44b…
Observed Orange Book patent history# Patent history page 1 of 131 · 5,208 observed states.
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