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N019625-001 | ELOCON | MOMETASONE FUROATE | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | 1987-05-06 | ||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N019625-002 | ELOCON | MOMETASONE FUROATE | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 2013-04-19 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N019625-001 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | 1987-05-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019625-002 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 2013-04-19 | 84e616aacf4f… | |
| 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| 2026-07 | N019625-001 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | 1987-05-06 | caaa826d4ba7… | ||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| 2026-07 | N019625-002 | ELOCON | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 2013-04-19 | caaa826d4ba7… | |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… |
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 |
|---|---|---|---|---|---|---|
| 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 |
| Mometasone Furoate | MOMETASONE FUROATE | Padagis Israel Pharmaceuticals Ltd | a12fef6b-681e-4f80-8bcd-3f01733f1a67 | 2025-07-07 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Mometasone Furoate | MOMETASONE FUROATE | Sun Pharmaceutical Industries, Inc. | ce61920d-65df-4423-925d-091e624ea32e | 2025-07-07 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| MOMETASONE FUROATE | MOMETASONE FUROATE | Aurohealth LLC | 48ba8c52-73b6-4ee9-ba13-756a645a9183 | 2024-11-25 | Warnings | MOMETASONE FUROATE |
| Mometasone Furoate | MOMETASONE FUROATE | Bryant Ranch Prepack | 43a91066-1d85-4f67-9856-a11c1bb2b22b | 2024-11-20 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Mometasone Furoate | MOMETASONE FUROATE | Bryant Ranch Prepack | 6c7d8133-b71e-4290-bec1-53ff0232998a | 2024-08-30 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Childrens Nasonex | MOMETASONE FUROATE | L. Perrigo Company | e15d055e-9a25-46b4-8724-3609cf2dc062 | 2024-08-28 | Warnings | MOMETASONE FUROATE |
| Mometasone Furoate | MOMETASONE FUROATE | Bryant Ranch Prepack | 45c9512b-9463-4684-bfdb-742644d77cc3 | 2024-08-14 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Mometasone Furoate | MOMETASONE FUROATE | Proficient Rx LP | 2bf06b19-4ed7-41a3-b6fc-29713c41965c | 2024-02-01 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Mometasone Furoate | MOMETASONE FUROATE | Cosette Pharmaceuticals, Inc. | f69603aa-a5a6-b8f3-c9ed-2d0abc9f4d92 | 2023-11-29 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Mometasone Furoate | MOMETASONE FUROATE | Cosette Pharmaceuticals, Inc. | f5b30e5e-b067-e28c-b7c5-aa58f4c57f09 | 2023-11-29 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Mometasone Furoate | MOMETASONE FUROATE | Bryant Ranch Prepack | c3053a64-9044-496e-9005-12b4440d46e8 | 2023-10-20 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Mometasone Furoate | MOMETASONE FUROATE | Bryant Ranch Prepack | d15edb8b-c8b2-4023-992e-f79cefa2d1e8 | 2023-08-16 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Mometasone Furoate | MOMETASONE FUROATE | Bryant Ranch Prepack | a6055a9c-e19c-48ad-a743-c0a7f7366cdd | 2023-07-18 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Mometasone Furoate | MOMETASONE FUROATE | Bryant Ranch Prepack | 5f1f2136-9e10-4d43-bb35-ed285c744fe4 | 2023-07-18 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Mometasone Furoate | MOMETASONE FUROATE | Padagis Israel Pharmaceuticals Ltd | 7296b4a2-f180-4887-a8e0-029f81aec566 | 2023-04-21 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Mometasone Furoate | MOMETASONE FUROATE | A-S Medication Solutions | 9fe65193-b4d8-480b-89b3-178cd1b20713 | 2023-02-15 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Sinuva | MOMETASONE FUROATE | Intersect ENT, Inc. | e33c1b23-cdc6-4f64-94ba-24b0b42c09bf | 2023-01-26 | Warnings, Adverse reactions | MOMETASONE FUROATE |
| Mometasone Furoate | MOMETASONE FUROATE | Proficient Rx LP | 47a60763-671e-413b-b962-f7f11ba2f4d7 | 2021-01-01 | Warnings, Adverse reactions | MOMETASONE FUROATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |