Home Applications 211950 Application 211950
Type NDA
Sponsor CLEARSIDE BIOMEDICAL, INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 XIPERE TRIAMCINOLONE ACETONIDE INJECTABLE; SUSPENSION 40MG/ML No 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 N211950-001 XIPERE TRIAMCINOLONE ACETONIDE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211950-001 8636713 2027-05-02 U-3234 2021-11-04 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 N211950-001 12419833 2040-04-16 U-3234 Drug product 2025-10-23
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 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 106 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 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211950-001 12419833 2040-04-16 U-3234 Drug product 2025-10-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211950-001 12419833 2040-04-16 U-3234 Drug product 2025-10-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211950-001 12419833 2040-04-16 U-3234 Drug product 2025-10-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 301d65b070ca…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Xipere TRIAMCINOLONE ACETONIDE Bausch & Lomb Incorporated ea6ad429-967f-4f75-a33d-e06f849bee80 2025-10-08 Warnings, Adverse reactions Exact identifier application applno (NDA): 211950 application number: NDA211950 ndc (product): 24208-040
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 24208-040 Xipere triamcinolone acetonide Bausch & Lomb Incorporated NDA Current 24208-040 Xipere triamcinolone acetonide Bausch & Lomb Incorporated NDA Current 24208-040 Xipere triamcinolone acetonide Bausch & Lomb Incorporated NDA Current 71565-040 Xipere triamcinolone acetonide Clearside Biomedical, Inc. NDA Current 71565-040 Xipere triamcinolone acetonide Clearside Biomedical, Inc. NDA Current 71565-040 Xipere triamcinolone acetonide Clearside Biomedical, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 82414 SUPPL 2025-06-02 82316 SUPPL 2025-05-27 72235 ORIG 2022-10-04 69105 ORIG 2021-10-25 69104 ORIG 2021-10-25