Application 018702
- Type
- NDA
- Sponsor
- FOUGERA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACLOVATE | ALCLOMETASONE DIPROPIONATE | OINTMENT;TOPICAL | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018702-001 | ACLOVATE | ALCLOMETASONE DIPROPIONATE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD | 1982-12-14 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N018702-001 | ACLOVATE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD | 1982-12-14 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N018702-001 | ACLOVATE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD | 1982-12-14 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N018702-001 | ACLOVATE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD | 1982-12-14 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N018702-001 | ACLOVATE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD | 1982-12-14 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Alclometasone Dipropionate | ALCLOMETASONE DIPROPIONATE | Sun Pharmaceutical Industries, Inc. | 3b0dccd6-dee1-49dd-8c6d-82df5c7ee36c | 2025-08-13 | Adverse reactions | ALCLOMETASONE DIPROPIONATE |
| Alclometasone dipropionate | ALCLOMETASONE DIPROPIONATE | Sun Pharmaceutical Industries, Inc. | 3e688309-880a-4890-bf00-90afd19084f6 | 2025-07-29 | Adverse reactions | ALCLOMETASONE DIPROPIONATE |
| Alclometasone Dipropionate | ALCLOMETASONE DIPROPIONATE | Glenmark Pharmaceuticals Inc., USA | 63e635e0-65d8-4b30-9f2a-ab16deba90bd | 2021-04-05 | Adverse reactions | ALCLOMETASONE DIPROPIONATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.