Home Applications 209363 Application 209363
Type NDA
Sponsor LUPIN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SOLOSEC SECNIDAZOLE GRANULE;ORAL 2GM/PACKET 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 N209363-001 SOLOSEC SECNIDAZOLE 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15
Orange Book patents# Current patent rows page 1 of 1 · 33 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209363-001 10335390 2035-09-04 U-2583 Drug product 2019-07-31 N209363-001 10335390 2035-09-04 U-3270 Drug product 2019-07-31 N209363-001 10682338 2035-09-04 U-2583 Drug product 2020-06-23 N209363-001 10682338 2035-09-04 U-3270 Drug product 2020-06-23 N209363-001 10849884 2035-09-04 U-2583 Drug product 2020-12-11 N209363-001 10849884 2035-09-04 U-3169 Drug product 2020-12-11 N209363-001 10849884 2035-09-04 U-3270 Drug product 2020-12-11 N209363-001 10849884 2035-09-04 U-3302 Drug product 2020-12-11 N209363-001 10857133 2035-09-04 U-2583 Drug product 2020-12-11 N209363-001 10857133 2035-09-04 U-3270 Drug product 2020-12-11 N209363-001 11000507 2035-09-04 U-2583 Drug product 2021-06-07 N209363-001 11000507 2035-09-04 U-3169 Drug product 2021-06-07 N209363-001 11000507 2035-09-04 U-3270 Drug product 2021-06-07 N209363-001 11000507 2035-09-04 U-3302 Drug product 2021-06-07 N209363-001 11000508 2035-09-04 U-2583 Drug product 2021-06-07 N209363-001 11000508 2035-09-04 U-3169 Drug product 2021-06-07 N209363-001 11000508 2035-09-04 U-3270 Drug product 2021-06-07 N209363-001 11000508 2035-09-04 U-3302 Drug product 2021-06-07 N209363-001 11020377 2035-09-04 U-2583 Drug product 2021-06-16 N209363-001 11020377 2035-09-04 U-3169 Drug product 2021-06-16 N209363-001 11020377 2035-09-04 U-3270 Drug product 2021-06-16 N209363-001 11020377 2035-09-04 U-3302 Drug product 2021-06-16 N209363-001 11324721 2035-09-04 U-2583 Drug product 2022-05-18 N209363-001 11324721 2035-09-04 U-3169 Drug product 2022-05-18 N209363-001 11324721 2035-09-04 U-3270 Drug product 2022-05-18 N209363-001 11324721 2035-09-04 U-3302 Drug product 2022-05-18 N209363-001 11602522 2035-09-04 U-3169 Drug product 2023-03-27 N209363-001 11602522 2035-09-04 U-3302 Drug product 2023-03-27 N209363-001 11684607 2035-09-16 U-2583 Drug product 2023-07-07 N209363-001 11684607 2035-09-16 U-3169 Drug product 2023-07-07 N209363-001 11684607 2035-09-16 U-3270 Drug product 2023-07-07 N209363-001 11684607 2035-09-16 U-3302 Drug product 2023-07-07 N209363-001 12280037 2041-12-11 U-3302 2025-05-19
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N209363-001 NCE 2022-09-15 N209363-001 GAIN 2027-09-15
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 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 26 · 1,002 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N209363-001 10335390 2035-09-04 U-2583 Drug product 2019-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 10335390 2035-09-04 U-3270 Drug product 2019-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 10682338 2035-09-04 U-3270 Drug product 2020-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 10682338 2035-09-04 U-2583 Drug product 2020-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 10849884 2035-09-04 U-3270 Drug product 2020-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 10849884 2035-09-04 U-3302 Drug product 2020-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 10849884 2035-09-04 U-3169 Drug product 2020-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 10849884 2035-09-04 U-2583 Drug product 2020-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 10857133 2035-09-04 U-3270 Drug product 2020-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 10857133 2035-09-04 U-2583 Drug product 2020-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11000507 2035-09-04 U-3302 Drug product 2021-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11000507 2035-09-04 U-3270 Drug product 2021-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11000507 2035-09-04 U-3169 Drug product 2021-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11000507 2035-09-04 U-2583 Drug product 2021-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11000508 2035-09-04 U-3302 Drug product 2021-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11000508 2035-09-04 U-3270 Drug product 2021-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11000508 2035-09-04 U-3169 Drug product 2021-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11000508 2035-09-04 U-2583 Drug product 2021-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11020377 2035-09-04 U-3302 Drug product 2021-06-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11020377 2035-09-04 U-3270 Drug product 2021-06-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11020377 2035-09-04 U-3169 Drug product 2021-06-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11020377 2035-09-04 U-2583 Drug product 2021-06-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11324721 2035-09-04 U-2583 Drug product 2022-05-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11324721 2035-09-04 U-3169 Drug product 2022-05-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11324721 2035-09-04 U-3270 Drug product 2022-05-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11324721 2035-09-04 U-3302 Drug product 2022-05-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11602522 2035-09-04 U-3169 Drug product 2023-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11602522 2035-09-04 U-3302 Drug product 2023-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11684607 2035-09-16 U-2583 Drug product 2023-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11684607 2035-09-16 U-3169 Drug product 2023-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11684607 2035-09-16 U-3270 Drug product 2023-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11684607 2035-09-16 U-3302 Drug product 2023-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 12280037 2041-12-11 U-3302 2025-05-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209363-001 10335390 2035-09-04 U-2583 Drug product 2019-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209363-001 10335390 2035-09-04 U-3270 Drug product 2019-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209363-001 10682338 2035-09-04 U-3270 Drug product 2020-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209363-001 10682338 2035-09-04 U-2583 Drug product 2020-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209363-001 10849884 2035-09-04 U-3270 Drug product 2020-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209363-001 10849884 2035-09-04 U-3302 Drug product 2020-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209363-001 10849884 2035-09-04 U-3169 Drug product 2020-12-11 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 140 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 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 27437-051 SOLOSEC secnidazole Lupin Pharmaceuticals, Inc. NDA Current 27437-051 SOLOSEC secnidazole Lupin Pharmaceuticals, Inc. NDA Current 27437-051 SOLOSEC secnidazole Lupin Pharmaceuticals, Inc. NDA Current 27437-051 SOLOSEC secnidazole Lupin Pharmaceuticals, Inc. NDA Current 27437-051 SOLOSEC secnidazole Lupin Pharmaceuticals, Inc. NDA Current 27437-051 SOLOSEC secnidazole Lupin Pharmaceuticals, Inc. NDA Current 27437-051 SOLOSEC secnidazole Lupin Pharmaceuticals, Inc. NDA Current 27437-051 SOLOSEC secnidazole Lupin Pharmaceuticals, Inc. NDA Current 64811-401 Solosec SECNIDAZOLE Ropack Inc. NDA Current