Home Applications 210867 Application 210867
Type NDA
Sponsor MDGH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MOXIDECTIN MOXIDECTIN TABLET;ORAL 2MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N210867-001 MOXIDECTIN MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N210867-001 NPP 2028-02-07 N210867-001 ODE-528 2032-02-07
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 · 42 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 2026-08-18 06:07:40 2026-07 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210867-001 MOXIDECTIN 2MG TABLET / ORAL RLD, RS 2018-06-13 e64feba35796…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 70 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 71705-050 Moxidectin Moxidectin Medicines Development for Global Health NDA Current 71705-050 Moxidectin Moxidectin Medicines Development Limited (trading as Medicines Development for Global Health) NDA Current 71705-050 Moxidectin Moxidectin Medicines Development for Global Health NDA Current 71705-051 Moxidectin Moxidectin Medicines Development for Global Health NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 81214 SUPPL 2025-02-11 81179 SUPPL 2025-02-10 66702 SUPPL 2021-03-09 66658 SUPPL 2021-03-09 57296 SUPPL 2019-01-22 57282 SUPPL 2019-01-22 54773 ORIG 2018-07-05 54547 ORIG 2018-06-14 54546 ORIG 2018-06-14