Application 208183
- Type
- NDA
- Sponsor
- SUN PHARM INDUSTRIES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ULTRAVATE | HALOBETASOL PROPIONATE | LOTION;TOPICAL | 0.05% | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 10631-122 | Ultravate | halobetasol propionate | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 10631-122 | Ultravate | halobetasol propionate | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 10631-122 | Ultravate | halobetasol propionate | Sun Pharmaceutical Industries, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 64502 | SUPPL | 2020-09-04 |
| 64441 | SUPPL | 2020-08-28 |
| 24535 | ORIG | 2016-06-29 |
| 23052 | ORIG | 2016-06-29 |
| 32896 | ORIG | 2015-11-13 |
| 40622 | ORIG | 2015-11-12 |