Application 017823
- Type
- NDA
- Sponsor
- SUN PHARM INDS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HALOG | HALCINONIDE | SOLUTION;TOPICAL | 0.1% | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017823-001 | HALOG | HALCINONIDE | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | AT | RLD, Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N017823-001 | AT |
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 | N017823-001 | HALOG | 0.1% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N017823-001 | HALOG | 0.1% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N017823-001 | HALOG | 0.1% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N017823-001 | HALOG | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | AT | RLD, Approved before 1982 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N017823-001 | AT | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N017823-001 | AT | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N017823-001 | AT | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N017823-001 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017823-001 | AT | 1 | 31067a03dcf5… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N017823-001 | AT | 1 | 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 |
|---|---|---|---|---|---|---|
| HALOG | HALCINONIDE TOPICAL | Genus Lifesciences Inc. | 42dc0904-1800-5f3b-e063-6294a90a2ad2 | 2025-11-05 | Adverse reactions | 017823 NDA017823 |
| HALOG | HALCINONIDE | E.R. Squibb & Sons, L.L.C. | f6c7e87b-6629-4d68-ae46-add64ca9daab | 2006-07-06 | Adverse reactions | 017823 NDA017823 0003-0249 |
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 |
|---|---|---|---|---|---|
| 0003-0249 | HALOG | Halcinonide | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 10631-095 | HALOG | Halcinonide Topical | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 10631-095 | HALOG | Halcinonide Topical | Sun Pharmaceutical Industries, Inc. | NDA | Current |