Application 074028
- Type
- ANDA
- Sponsor
- ANDA REPOSITORY
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | SYRUP;ORAL | 50MG/5ML | No | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46672-606 | amantadine hydrochloride | amantadine hydrochloride | Mikart, Inc. | ANDA | Current |
| 46672-606 | amantadine hydrochloride | amantadine hydrochloride | Mikart, LLC | ANDA | Current |
| 62135-010 | Amantadine Hydrochloride | Amantadine Hydrochloride | Chartwell RX, LLC | ANDA | Current |