Application 009112
- Type
- NDA
- Sponsor
- SUN PHARM INDS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 003 | EURAX | CROTAMITON | LOTION;TOPICAL | 10% | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 10631-092 | Eurax | crotamiton | Ranbaxy Laboratories Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 175 | SUPPL | 2009-07-15 |
| 10717 | SUPPL | 2003-07-08 |
| 124 | SUPPL | 2003-07-06 |