Application 017556
- 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 | CREAM;TOPICAL | 0.1% | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 10631-094 | Halog | Halcinonide Cream | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 57664-698 | HALCINONIDE | HALCINONIDE | Sun Pharmaceutical Industries, Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 11025 | SUPPL | 2009-06-22 |
| 13846 | SUPPL | 2009-06-16 |
| 33301 | SUPPL | 2004-10-04 |
| 636 | SUPPL | 2004-10-04 |