Home Applications 201820 Application 201820
Type NDA
Sponsor CHIESI Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BETHKIS TOBRAMYCIN SOLUTION;INHALATION 300MG/4ML 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 N201820-001 BETHKIS TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N201820-001 AN
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 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION RLD, RS 2012-10-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION RLD, RS 2012-10-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION RLD, RS 2012-10-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 2 · 54 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 ea99ee380514…2023-01-26 05:58 UTC 2023-01 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 3bdfa0b2c4d7…
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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 10122-820 BETHKIS tobramycin Chiesi USA, Inc. NDA Current 10122-820 BETHKIS tobramycin Chiesi USA, Inc. NDA Current 10122-820 BETHKIS tobramycin Chiesi USA, Inc. NDA Current 10122-820 BETHKIS tobramycin Chiesi USA, Inc. NDA Current 66993-195 Tobramycin Inhalation tobramycin inhalation Prasco, LLC NDA AUTHORIZED GENERIC Current 66993-195 Tobramycin Inhalation tobramycin inhalation Prasco, LLC NDA AUTHORIZED GENERIC Current 66993-195 Tobramycin Inhalation tobramycin inhalation Prasco, LLC NDA AUTHORIZED GENERIC Current