Home Applications 210913 Application 210913
Type NDA
Sponsor SUN PHARMA GLOBAL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CEQUA CYCLOSPORINE SOLUTION;OPHTHALMIC 0.09% 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 N210913-001 CEQUA CYCLOSPORINE 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210913-001 10441630 2033-08-23 Drug product 2019-11-14 N210913-001 8980839 2033-08-23 U-1483 Drug product 2018-08-17 N210913-001 9937225 2033-08-23 U-1483 Drug product 2018-08-17 N210913-001 10918694 2037-02-28 Drug product 2021-03-18 N210913-001 11951153 2037-02-28 U-1483 2024-05-02
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 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 5 · 169 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N210913-001 10441630 2033-08-23 Drug product 2019-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210913-001 8980839 2033-08-23 U-1483 Drug product 2018-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210913-001 9937225 2033-08-23 U-1483 Drug product 2018-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210913-001 10918694 2037-02-28 Drug product 2021-03-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210913-001 11951153 2037-02-28 U-1483 2024-05-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210913-001 10441630 2033-08-23 Drug product 2019-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210913-001 8980839 2033-08-23 U-1483 Drug product 2018-08-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210913-001 9937225 2033-08-23 U-1483 Drug product 2018-08-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210913-001 10918694 2037-02-28 Drug product 2021-03-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210913-001 11951153 2037-02-28 U-1483 2024-05-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210913-001 10441630 2033-08-23 Drug product 2019-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210913-001 8980839 2033-08-23 U-1483 Drug product 2018-08-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210913-001 9937225 2033-08-23 U-1483 Drug product 2018-08-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210913-001 10918694 2037-02-28 Drug product 2021-03-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210913-001 11951153 2037-02-28 U-1483 2024-05-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210913-001 10441630 2033-08-23 Drug product 2019-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210913-001 8980839 2033-08-23 U-1483 Drug product 2018-08-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210913-001 9937225 2033-08-23 U-1483 Drug product 2018-08-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210913-001 10918694 2037-02-28 Drug product 2021-03-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210913-001 11951153 2037-02-28 U-1483 2024-05-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210913-001 10441630 2033-08-23 Drug product 2019-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210913-001 8980839 2033-08-23 U-1483 Drug product 2018-08-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210913-001 9937225 2033-08-23 U-1483 Drug product 2018-08-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210913-001 10918694 2037-02-28 Drug product 2021-03-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210913-001 11951153 2037-02-28 U-1483 2024-05-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210913-001 10441630 2033-08-23 Drug product 2019-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210913-001 8980839 2033-08-23 U-1483 Drug product 2018-08-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210913-001 9937225 2033-08-23 U-1483 Drug product 2018-08-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210913-001 10918694 2037-02-28 Drug product 2021-03-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210913-001 11951153 2037-02-28 U-1483 2024-05-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210913-001 10441630 2033-08-23 Drug product 2019-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210913-001 8980839 2033-08-23 U-1483 Drug product 2018-08-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210913-001 9937225 2033-08-23 U-1483 Drug product 2018-08-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210913-001 10918694 2037-02-28 Drug product 2021-03-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210913-001 11951153 2037-02-28 U-1483 2024-05-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210913-001 10441630 2033-08-23 Drug product 2019-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210913-001 8980839 2033-08-23 U-1483 Drug product 2018-08-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210913-001 9937225 2033-08-23 U-1483 Drug product 2018-08-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210913-001 10918694 2037-02-28 Drug product 2021-03-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210913-001 11951153 2037-02-28 U-1483 2024-05-02 5bbf6a4d5a75…
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 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 47335-506 CEQUA cyclosporine Sun Pharmaceutical Industries, Inc. NDA Current 47335-506 CEQUA cyclosporine Sun Pharmaceutical Industries, Inc. NDA Current 47335-506 CEQUA cyclosporine Sun Pharmaceutical Industries, Inc. NDA Current 47335-506 CEQUA cyclosporine Sun Pharmaceutical Industries, Inc. NDA Current 47335-506 CEQUA cyclosporine Sun Pharmaceutical Industries, Inc. NDA Current 47335-506 CEQUA cyclosporine Sun Pharmaceutical Industries, Inc. NDA Current 47335-507 CEQUA cyclosporine Sun Pharmaceutical Industries, Inc. NDA Current 47335-507 CEQUA cyclosporine Sun Pharmaceutical Industries, Inc. NDA Current 47335-507 CEQUA cyclosporine Sun Pharmaceutical Industries, Inc. NDA Current 47335-507 CEQUA cyclosporine Sun Pharmaceutical Industries, Inc. NDA Current 47335-507 CEQUA cyclosporine Sun Pharmaceutical Industries, Inc. NDA Current 47335-507 CEQUA cyclosporine Sun Pharmaceutical Industries, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 60090 SUPPL 2019-09-23 60087 SUPPL 2019-09-23 58059 ORIG 2019-03-21 55212 ORIG 2018-08-20 55175 ORIG 2018-08-15