Home Applications 201688 Application 201688
Type NDA
Sponsor MYLAN SPECIALITY LP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TOBI PODHALER TOBRAMYCIN POWDER;INHALATION 28MG 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 N201688-001 TOBI PODHALER TOBRAMYCIN 28MG POWDER / INHALATION RLD, RS 2013-03-22
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 N201688-001 8869794 2028-09-12 U-909 Drug product 2019-06-17 N201688-001 10207066 2030-11-04 U-909 Drug product 2019-06-17
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 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N201688-001 TOBI PODHALER 28MG POWDER / INHALATION RLD, RS 2013-03-22 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 9 · 331 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 N201688-001 8869794 2028-09-12 U-909 Drug product 2019-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201688-001 10207066 2030-11-04 U-909 Drug product 2019-06-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201688-001 8664187 2025-06-20 U-909 2019-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201688-001 7559325 2025-10-27 Drug product 2013-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201688-001 8869794 2028-09-12 U-909 Drug product 2019-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201688-001 10207066 2030-11-04 U-909 Drug product 2019-06-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201688-001 8664187 2025-06-20 U-909 2019-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201688-001 7559325 2025-10-27 Drug product 2013-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201688-001 8869794 2028-09-12 U-909 Drug product 2019-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201688-001 10207066 2030-11-04 U-909 Drug product 2019-06-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201688-001 8664187 2025-06-20 U-909 2019-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201688-001 7559325 2025-10-27 Drug product 2013-04-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201688-001 8869794 2028-09-12 U-909 Drug product 2019-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201688-001 10207066 2030-11-04 U-909 Drug product 2019-06-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201688-001 8664187 2025-06-20 U-909 2019-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201688-001 7559325 2025-10-27 Drug product 2013-04-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201688-001 8869794 2028-09-12 U-909 Drug product 2019-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201688-001 10207066 2030-11-04 U-909 Drug product 2019-06-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201688-001 7516741 2024-01-11 Drug product 2013-04-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201688-001 RE47526 2024-04-09 Drug product 2020-06-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201688-001 11484671 2024-11-07 U-909 Drug product 2022-11-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201688-001 8664187 2025-06-20 U-909 2019-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201688-001 7559325 2025-10-27 Drug product 2013-04-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201688-001 8869794 2028-09-12 U-909 Drug product 2019-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201688-001 10207066 2030-11-04 U-909 Drug product 2019-06-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201688-001 7516741 2024-01-11 Drug product 2013-04-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201688-001 RE47526 2024-04-09 Drug product 2020-06-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201688-001 11484671 2024-11-07 U-909 Drug product 2022-11-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201688-001 8664187 2025-06-20 U-909 2019-06-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201688-001 7559325 2025-10-27 Drug product 2013-04-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201688-001 8869794 2028-09-12 U-909 Drug product 2019-06-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201688-001 10207066 2030-11-04 U-909 Drug product 2019-06-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201688-001 7516741 2024-01-11 Drug product 2013-04-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201688-001 RE47526 2024-04-09 Drug product 2020-06-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201688-001 11484671 2024-11-07 U-909 Drug product 2022-11-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201688-001 8664187 2025-06-20 U-909 2019-06-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201688-001 7559325 2025-10-27 Drug product 2013-04-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201688-001 8869794 2028-09-12 U-909 Drug product 2019-06-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201688-001 10207066 2030-11-04 U-909 Drug product 2019-06-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201688-001 7516741 2024-01-11 Drug product 2013-04-19 d8e5a09893c0…
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 · 19 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-0630 TOBI Podhaler Tobramycin Novartis Pharmaceuticals Corporation NDA Current 0078-0630 TOBI Podhaler Tobramycin Novartis Pharmaceuticals Corporation NDA Current 0078-0630 TOBI Podhaler Tobramycin Novartis Pharmaceuticals Corporation NDA Current 0078-0630 TOBI Podhaler Tobramycin Novartis Pharmaceuticals Corporation NDA Current 0078-0630 TOBI Podhaler Tobramycin Novartis Pharmaceuticals Corporation NDA Current 0078-0630 TOBI Podhaler Tobramycin Novartis Pharmaceuticals Corporation NDA Current 49502-346 TOBI Podhaler Tobramycin Mylan Specialty L.P. NDA Current 49502-346 TOBI Podhaler Tobramycin Mylan Specialty L.P. NDA Current 49502-346 TOBI Podhaler Tobramycin Mylan Specialty L.P. NDA Current 49502-346 TOBI Podhaler Tobramycin Mylan Specialty L.P. NDA Current 49502-346 TOBI Podhaler Tobramycin Mylan Specialty L.P. NDA Current 49502-346 TOBI Podhaler Tobramycin Mylan Specialty L.P. NDA Current 49502-346 TOBI Podhaler Tobramycin Mylan Specialty L.P. NDA Current 49502-346 TOBI Podhaler Tobramycin Mylan Specialty L.P. NDA Current 49502-346 TOBI Podhaler Tobramycin Mylan Specialty L.P. NDA Current 49502-401 TOBI Podhaler Tobramycin Mylan Specialty L.P. NDA Current 49502-401 TOBI Podhaler Tobramycin Mylan Specialty L.P. NDA Current 49502-401 TOBI Podhaler Tobramycin Mylan Specialty L.P. NDA Current 49502-401 TOBI Podhaler Tobramycin Mylan Specialty L.P. NDA Current