Home Applications 212157 Application 212157
Type NDA
Sponsor DR REDDYS LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ELYXYB CELECOXIB SOLUTION;ORAL 120MG/4.8ML(25MG/ML) Yes No
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 N212157-001 ELYXYB CELECOXIB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212157-001 10376527 2036-05-27 U-2718 Drug product 2020-05-11 N212157-001 10722456 2036-05-27 U-2718 Drug product 2020-08-14 N212157-001 10799517 2036-05-27 U-2718 Drug product 2020-10-28 N212157-001 9572819 2036-05-27 U-2718 Drug product 2020-05-11 N212157-001 9795620 2036-05-27 U-2718 Drug product 2020-05-11 N212157-001 9949990 2036-05-27 U-2718 Drug product 2020-05-11
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.
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 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD 2020-05-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD 2020-05-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD 2020-05-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD 2020-05-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD 2020-05-05 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD 2020-05-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD 2020-05-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD 2020-05-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD 2020-05-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD 2020-05-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD 2020-05-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 6 · 227 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 N212157-001 10376527 2036-05-27 U-2718 Drug product 2020-05-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212157-001 10722456 2036-05-27 U-2718 Drug product 2020-08-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212157-001 10799517 2036-05-27 U-2718 Drug product 2020-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212157-001 9572819 2036-05-27 U-2718 Drug product 2020-05-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212157-001 9795620 2036-05-27 U-2718 Drug product 2020-05-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212157-001 9949990 2036-05-27 U-2718 Drug product 2020-05-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212157-001 10376527 2036-05-27 U-2718 Drug product 2020-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212157-001 10722456 2036-05-27 U-2718 Drug product 2020-08-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212157-001 10799517 2036-05-27 U-2718 Drug product 2020-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212157-001 9572819 2036-05-27 U-2718 Drug product 2020-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212157-001 9795620 2036-05-27 U-2718 Drug product 2020-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212157-001 9949990 2036-05-27 U-2718 Drug product 2020-05-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212157-001 10376527 2036-05-27 U-2718 Drug product 2020-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212157-001 10722456 2036-05-27 U-2718 Drug product 2020-08-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212157-001 10799517 2036-05-27 U-2718 Drug product 2020-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212157-001 9572819 2036-05-27 U-2718 Drug product 2020-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212157-001 9795620 2036-05-27 U-2718 Drug product 2020-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212157-001 9949990 2036-05-27 U-2718 Drug product 2020-05-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212157-001 10376527 2036-05-27 U-2718 Drug product 2020-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212157-001 10722456 2036-05-27 U-2718 Drug product 2020-08-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212157-001 10799517 2036-05-27 U-2718 Drug product 2020-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212157-001 9572819 2036-05-27 U-2718 Drug product 2020-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212157-001 9795620 2036-05-27 U-2718 Drug product 2020-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212157-001 9949990 2036-05-27 U-2718 Drug product 2020-05-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212157-001 10376527 2036-05-27 U-2718 Drug product 2020-05-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212157-001 10722456 2036-05-27 U-2718 Drug product 2020-08-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212157-001 10799517 2036-05-27 U-2718 Drug product 2020-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212157-001 9572819 2036-05-27 U-2718 Drug product 2020-05-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212157-001 9795620 2036-05-27 U-2718 Drug product 2020-05-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212157-001 9949990 2036-05-27 U-2718 Drug product 2020-05-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212157-001 10376527 2036-05-27 U-2718 Drug product 2020-05-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212157-001 10722456 2036-05-27 U-2718 Drug product 2020-08-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212157-001 10799517 2036-05-27 U-2718 Drug product 2020-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212157-001 9572819 2036-05-27 U-2718 Drug product 2020-05-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212157-001 9795620 2036-05-27 U-2718 Drug product 2020-05-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212157-001 9949990 2036-05-27 U-2718 Drug product 2020-05-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212157-001 10376527 2036-05-27 U-2718 Drug product 2020-05-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212157-001 10722456 2036-05-27 U-2718 Drug product 2020-08-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212157-001 10799517 2036-05-27 U-2718 Drug product 2020-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212157-001 9572819 2036-05-27 U-2718 Drug product 2020-05-11 03ed91905a0d…
Observed Orange Book exclusivity history# 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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 43598-866 ELYXYB Celecoxib Dr. Reddy NDA Current 59385-055 ELYXYB - celecoxib celecoxib BioDelivery Sciences International Inc NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 80405 SUPPL 2024-11-25 80404 SUPPL 2024-11-25 80319 SUPPL 2024-11-22 67351 SUPPL 2021-05-03 67296 SUPPL 2021-04-30 64110 ORIG 2020-07-28 62836 ORIG 2020-05-06 62827 ORIG 2020-05-05 62826 ORIG 2020-05-05