Application 076498
- Type
- ANDA
- Sponsor
- ZO SKIN HEALTH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRETINOIN | TRETINOIN | CREAM;TOPICAL | 0.05% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42851-011 | Tretinoin (Emollient) | Tretinoin | ZO Skin Health, Inc. | ANDA | Current |
| 42851-011 | Tretinoin (Emollient) | Tretinoin | ZO Skin Health, Inc. | ANDA | Current |
| 42851-012 | Refissa Tretinoin (Emollient) | Tretinoin | ZO Skin Health, Inc. | ANDA | Current |
| 42851-012 | Refissa Tretinoin (Emollient) | Tretinoin | ZO Skin Health, Inc. | ANDA | Current |
| 42851-012 | Refissa Tretinoin (Emollient) | Tretinoin | ZO Skin Health, Inc. | ANDA | Current |
| 50224-002 | Refissa | Tretinoin | Suneva Medical, Inc. | ANDA | Current |
| 50224-002 | REFISSA | TRETINOIN | Suneva Medical, Inc. | ANDA | Current |