Application 206165
- Type
- ANDA
- Sponsor
- TOLMAR
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NAFTIFINE HYDROCHLORIDE | NAFTIFINE HYDROCHLORIDE | GEL;TOPICAL | 1% | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0115-1510 | NAFTIFINE HYDROCHLORIDE | NAFTIFINE HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 58402 | ORIG | 2019-04-24 |