Application 019625
- Type
- NDA
- Sponsor
- MERCK SHARP DOHME
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ELOCON | MOMETASONE FUROATE | CREAM;TOPICAL | 0.1% | No | No |
| 002 | ELOCON | MOMETASONE FUROATE | CREAM;TOPICAL | 0.1% | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019625-001 | ELOCON | MOMETASONE FUROATE | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | 1987-05-06 | ||
| N019625-002 | ELOCON | MOMETASONE FUROATE | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 2013-04-19 |
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 | 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| 2026-07 | N019625-001 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | 1987-05-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019625-002 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 2013-04-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019625-001 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | 1987-05-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019625-002 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 2013-04-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019625-001 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | 1987-05-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019625-002 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 2013-04-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019625-001 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | 1987-05-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019625-002 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 2013-04-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019625-001 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | 1987-05-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019625-002 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 2013-04-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019625-001 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | 1987-05-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019625-002 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 2013-04-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019625-001 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | 1987-05-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019625-002 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 2013-04-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019625-001 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | 1987-05-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019625-002 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 2013-04-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019625-001 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | 1987-05-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019625-002 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 2013-04-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019625-001 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | 1987-05-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019625-002 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 2013-04-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019625-001 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | 1987-05-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019625-002 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 2013-04-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019625-001 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | 1987-05-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019625-002 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 2013-04-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019625-001 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | 1987-05-06 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019625-002 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 2013-04-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019625-001 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | 1987-05-06 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019625-002 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 2013-04-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019625-001 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | 1987-05-06 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019625-002 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 2013-04-19 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019625-001 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | 1987-05-06 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019625-002 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 2013-04-19 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019625-001 | ELOCON | 0.1% | CREAM / TOPICAL | 1987-05-06 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019625-002 | ELOCON | 0.1% | CREAM / TOPICAL | RLD | 2013-04-19 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019625-001 | ELOCON | 0.1% | CREAM / TOPICAL | 1987-05-06 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019625-002 | ELOCON | 0.1% | CREAM / TOPICAL | RLD | 2013-04-19 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019625-001 | ELOCON | 0.1% | CREAM / TOPICAL | 1987-05-06 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019625-002 | ELOCON | 0.1% | CREAM / TOPICAL | RLD | 2013-04-19 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N019625-001 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | 1987-05-06 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N019625-002 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 2013-04-19 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-07-19 19:46 UTC | 2019-07 | N019625-002 | AB | 1 | ea99ee380514… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Mometasone Furoate | MOMETASONE FUROATE | Torrent Pharmaceuticals Limited | 18ef90de-f74d-492f-a125-49da1875bd29 | 2026-08-06 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Mometasone Furoate | MOMETASONE FUROATE | Preferred Pharmaceuticals Inc. | 831f7694-8153-4a79-a453-48020b26f035 | 2026-07-17 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Mometasone Furoate | MOMETASONE FUROATE | Preferred Pharmaceuticals Inc. | bfe3d098-a5f8-4e5d-9fa6-eac167bad3e9 | 2026-07-17 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| ASMANEX | MOMETASONE FUROATE | Organon LLC | 10b36fb2-6b0d-4f20-b197-3564d6f594b9 | 2026-07-07 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| ASMANEX HFA | MOMETASONE FUROATE | Organon LLC | 0c6d63da-41bc-4894-bead-198e66c848ac | 2026-07-07 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Mometasone Furoate | MOMETASONE FUROATE | Bryant Ranch Prepack | 5eda1256-001a-4f40-b3ca-15349d532033 | 2026-05-21 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Mometasone furoate | MOMETASONE FUROATE | Encube Ethicals, Inc. | dae3eaea-fc17-48a2-ae30-2a68f7811bce | 2026-04-06 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Mometasone Furoate | MOMETASONE FUROATE | Sportpharm LLC | f02dea3f-9e4f-4c5a-bea3-f428afca803b | 2026-03-19 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Mometasone Furoate | MOMETASONE FUROATE | Preferred Pharmaceuticals Inc. | ad47cceb-e471-48d6-85d6-e4a3f10e2ac6 | 2026-01-27 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Mometasone Furoate | MOMETASONE FUROATE | A-S Medication Solutions | 16e134c7-39fb-4d16-9c24-a6df438967bf | 2026-01-23 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| ALLERGY RELIEF | MOMETASONE FUROATE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 97681a68-c26a-4ec9-ac67-4480878fa43d | 2026-01-05 | Warnings | MOMETASONE FUROATE |
| Mometasone Furoate | MOMETASONE FUROATE | Bryant Ranch Prepack | c953bd40-8a52-4812-837a-baaf1b17b3aa | 2025-10-29 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Mometasone Furoate | MOMETASONE FUROATE | Bryant Ranch Prepack | 88f5622d-64da-42b7-8aa9-62a5da5ebfbb | 2025-10-24 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| MOMETASONE FUROATE | MOMETASONE FUROATE | Encube Ethicals, Inc. | 1ebaac16-432e-4e92-9d58-718bd76ae368 | 2025-09-15 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Mometasone Furoate | MOMETASONE FUROATE | Bryant Ranch Prepack | 79e13e15-5bd3-48b1-877a-1cd92abbc7c5 | 2025-09-08 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Mometasone Furoate | MOMETASONE FUROATE | Bryant Ranch Prepack | 2f79063c-f7da-4e71-b054-d24b86dd386a | 2025-09-05 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Nasonex | MOMETASONE FUROATE | L. Perrigo Company | 13696a8b-366a-4a5e-adea-d5b7bff9e46f | 2025-08-19 | Warnings | MOMETASONE FUROATE |
| Leader Allergy Nasal | MOMETASONE FUROATE | Cardinal Health 110, LLC. dba Leader | 26f929e8-0759-4584-a0bf-f7709baa6bee | 2025-08-11 | Warnings | MOMETASONE FUROATE |
| Rugby mometasone furoate nasal | MOMETASONE FUROATE | Rugby Laboratories | b4c43535-ad22-44c2-b04f-df4348a6c485 | 2025-08-06 | Warnings | MOMETASONE FUROATE |
| MOMETASONE FUROATE | MOMETASONE FUROATE | Golden State Medical Supply, Inc. | e30ca373-d9c0-4cad-b5c3-3be9c299dddc | 2025-07-10 | Warnings, Adverse reactions | MOMETASONE FUROATE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0085-3149 | ELOCON | Mometasone Furoate | Merck Sharp & Dohme Corp. | NDA | Current |
| 0085-3149 | ELOCON | Mometasone Furoate | Merck Sharp & Dohme Corp. | NDA | Current |
| 0085-3149 | ELOCON | Mometasone Furoate | Merck Sharp & Dohme Corp. | NDA | Current |
| 0085-3149 | ELOCON | Mometasone Furoate | Merck Sharp & Dohme Corp. | NDA | Current |