Home Applications 208791 Application 208791
Type NDA
Sponsor B BRAUN MEDICAL INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CLOROTEKAL CHLOROPROCAINE HYDROCHLORIDE SOLUTION;INTRATHECAL 50MG/5ML (10MG/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 N208791-001 CLOROTEKAL CHLOROPROCAINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208791-001 8969412 2026-09-05 U-2609 Drug product 2019-09-03 N208791-001 9504666 2033-12-11 Drug product 2019-09-03
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 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208791-001 CLOROTEKAL 50MG/5ML (10MG/ML) SOLUTION / INTRATHECAL RLD 2017-09-26 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 3 · 82 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 N208791-001 8969412 2026-09-05 U-2609 Drug product 2019-09-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208791-001 9504666 2033-12-11 Drug product 2019-09-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208791-001 8969412 2026-09-05 U-2609 Drug product 2019-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208791-001 9504666 2033-12-11 Drug product 2019-09-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208791-001 8969412 2026-09-05 U-2609 Drug product 2019-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208791-001 9504666 2033-12-11 Drug product 2019-09-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208791-001 8969412 2026-09-05 U-2609 Drug product 2019-09-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208791-001 9504666 2033-12-11 Drug product 2019-09-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208791-001 8969412 2026-09-05 U-2609 Drug product 2019-09-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208791-001 9504666 2033-12-11 Drug product 2019-09-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208791-001 8969412 2026-09-05 U-2609 Drug product 2019-09-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208791-001 9504666 2033-12-11 Drug product 2019-09-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208791-001 8969412 2026-09-05 U-2609 Drug product 2019-09-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208791-001 9504666 2033-12-11 Drug product 2019-09-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208791-001 8969412 2026-09-05 U-2609 Drug product 2019-09-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208791-001 9504666 2033-12-11 Drug product 2019-09-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208791-001 8969412 2026-09-05 U-2609 Drug product 2019-09-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208791-001 9504666 2033-12-11 Drug product 2019-09-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208791-001 8969412 2026-09-05 U-2609 Drug product 2019-09-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208791-001 9504666 2033-12-11 Drug product 2019-09-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208791-001 8969412 2026-09-05 U-2609 Drug product 2019-09-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208791-001 9504666 2033-12-11 Drug product 2019-09-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208791-001 8969412 2026-09-05 U-2609 Drug product 2019-09-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208791-001 9504666 2033-12-11 Drug product 2019-09-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208791-001 8969412 2026-09-05 U-2609 Drug product 2019-09-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208791-001 9504666 2033-12-11 Drug product 2019-09-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208791-001 8969412 2026-09-05 U-2609 Drug product 2019-09-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208791-001 9504666 2033-12-11 Drug product 2019-09-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208791-001 8969412 2026-09-05 U-2609 Drug product 2019-09-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N208791-001 9504666 2033-12-11 Drug product 2019-09-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208791-001 8969412 2026-09-05 U-2609 Drug product 2019-09-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208791-001 9504666 2033-12-11 Drug product 2019-09-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208791-001 8969412 2026-09-05 U-2609 Drug product 2019-09-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N208791-001 9504666 2033-12-11 Drug product 2019-09-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208791-001 8969412 2026-09-05 U-2609 Drug product 2019-09-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N208791-001 9504666 2033-12-11 Drug product 2019-09-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208791-001 8969412 2026-09-05 U-2609 Drug product 2019-09-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208791-001 9504666 2033-12-11 Drug product 2019-09-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208791-001 8969412 2026-09-05 U-2609 Drug product 2019-09-03 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N208791-001 9504666 2033-12-11 Drug product 2019-09-03 bb7c543d1eb4…
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 · 3 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0264-7055 Clorotekal CHLOROPROCAINE HYDROCHLORIDE B. Braun Medical Inc. NDA Current 0264-7055 Clorotekal CHLOROPROCAINE HYDROCHLORIDE B. Braun Medical Inc. NDA Current 0264-7055 Clorotekal CHLOROPROCAINE HYDROCHLORIDE B. Braun Medical Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 53078 ORIG 2018-03-21 49875 ORIG 2017-09-28 49869 ORIG 2017-09-28