Home Applications 021067 Application 021067
Type NDA
Sponsor MERCK SHARP DOHME Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ASMANEX TWISTHALER MOMETASONE FUROATE POWDER;INHALATION 0.22MG/INH Yes Yes 002 ASMANEX TWISTHALER MOMETASONE FUROATE POWDER;INHALATION 0.11MG/INH Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021067-001 ASMANEX TWISTHALER MOMETASONE FUROATE 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 N021067-002 ASMANEX TWISTHALER MOMETASONE FUROATE 0.11MG/INH POWDER / INHALATION RLD, RS 2008-02-01
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 3 · 84 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 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD, RS 2008-02-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD, RS 2008-02-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 bb7c543d1eb4…
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 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0085-1341 ASMANEX Mometasone Furoate Merck Sharp & Dohme Corp. NDA Current 0085-1341 ASMANEX Mometasone Furoate Merck Sharp & Dohme Corp. NDA Current 0085-1341 ASMANEX Mometasone Furoate Merck Sharp & Dohme Corp. NDA Current 0085-1341 ASMANEX Mometasone Furoate Merck Sharp & Dohme Corp. NDA Current 0085-1341 ASMANEX Mometasone Furoate Merck Sharp & Dohme Corp. NDA Current 0085-1461 ASMANEX Mometasone Furoate Merck Sharp & Dohme Corp. NDA Current 0085-1461 ASMANEX Mometasone Furoate Merck Sharp & Dohme Corp. NDA Current 0085-1461 ASMANEX Mometasone Furoate Merck Sharp & Dohme Corp. NDA Current 0085-1461 ASMANEX Mometasone Furoate Merck Sharp & Dohme Corp. NDA Current 0085-1461 ASMANEX Mometasone Furoate Merck Sharp & Dohme Corp. NDA Current 78206-114 ASMANEX Mometasone Furoate Organon LLC NDA Current 78206-114 ASMANEX Mometasone Furoate Organon LLC NDA Current 78206-114 ASMANEX Mometasone Furoate Organon LLC NDA Current 78206-115 ASMANEX Mometasone Furoate Organon LLC NDA Current 78206-115 ASMANEX Mometasone Furoate Organon LLC NDA Current 78206-115 ASMANEX Mometasone Furoate Organon LLC NDA Current