Home Applications 018680 Application 018680
Type NDA
Sponsor COOPERSURGICAL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PARAGARD T 380A COPPER INTRAUTERINE DEVICE;INTRAUTERINE 309MG/COPPER Yes Yes
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 N018680-001 PARAGARD T 380A COPPER 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N018680-001 D-193 2027-06-28
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 cb3db0bc1861…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-02-19 14:30 UTC 2026-02 N018680-001 D-193 2027-06-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018680-001 D-193 2027-06-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018680-001 D-193 2027-06-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018680-001 D-193 2027-06-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018680-001 D-193 2027-06-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018680-001 D-193 2027-06-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018680-001 D-193 2027-06-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018680-001 D-193 2027-06-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018680-001 D-193 2027-06-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018680-001 D-193 2027-06-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018680-001 D-193 2027-06-28 79d66fd596c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N018680-001 D-193 2027-06-28 a50c72e98297…
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 · 2 matching rows.
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 51285-204 ParaGard T 380A Copper Teva Women's Health, Inc. NDA Current 51285-204 ParaGard T 380A Copper Teva Women's Health, Inc. NDA Current 59365-5128 ParaGard T 380A Copper CooperSurgical, Inc. NDA Current 59365-5128 ParaGard T 380A Copper CooperSurgical, Inc. NDA Current 59365-5128 ParaGard T 380A Copper CooperSurgical, Inc. NDA Current 59365-5128 ParaGard T 380A Copper CooperSurgical, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 78948 SUPPL 2024-09-16 82760 SUPPL 2024-07-01 59935 SUPPL 2019-09-11 59934 SUPPL 2019-09-11 59930 SUPPL 2019-09-06 59928 SUPPL 2019-09-06 33555 SUPPL 2013-06-18 1020 SUPPL 2013-06-13 20148 ORIG 2011-02-15 15088 SUPPL 2005-09-08 11275 SUPPL 2005-09-08 1019 SUPPL 2003-05-29 33554 SUPPL 2003-04-30