Application 017823
- Type
- NDA
- Sponsor
- SUN PHARM INDS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HALOG | HALCINONIDE | SOLUTION;TOPICAL | 0.1% | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| 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 |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 78466 | SUPPL | 2024-05-15 |
| 78465 | SUPPL | 2024-05-15 |
| 33355 | SUPPL | 2004-10-04 |
| 13913 | SUPPL | 2004-10-04 |