Application 019967
- Type
- NDA
- Sponsor
- SUN PHARM INDS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ULTRAVATE | HALOBETASOL PROPIONATE | CREAM;TOPICAL | 0.05% | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 10631-103 | Ultravate | halobetasol propionate | Ranbaxy Laboratories Inc. | NDA | Current |
| 10631-121 | Ultravate X | Halobetasol Propionate | Ranbaxy Laboratories Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 19912 | SUPPL | 2012-04-04 |
| 34167 | SUPPL | 2012-04-02 |
| 41113 | SUPPL | 2007-08-06 |
| 34166 | SUPPL | 2004-09-17 |
| 1877 | SUPPL | 2004-09-17 |
| 19911 | SUPPL | 2003-04-18 |
| 34165 | SUPPL | 2003-04-07 |