Application 020508
- Type
- NDA
- Sponsor
- SUN PHARM INDS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LAC-HYDRIN | AMMONIUM LACTATE | CREAM;TOPICAL | EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 10631-099 | Lac Hydrin | ammonium lactate | Ranbaxy Laboratories Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 12655 | SUPPL | 2004-12-30 |
| 25075 | SUPPL | 2004-12-22 |
| 20688 | SUPPL | 2001-12-11 |
| 34737 | SUPPL | 2000-08-25 |
| 25074 | SUPPL | 2000-08-25 |