Application 077919
- Type
- ANDA
- Sponsor
- HARRIS PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TERBINAFINE HYDROCHLORIDE | TERBINAFINE HYDROCHLORIDE | TABLET;ORAL | EQ 250MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67405-543 | Terbinafine | Terbinafine | HARRIS Pharmaceutical, Inc. | ANDA | Current |
| 68788-9094 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | Preferred Pharmaceuticals, Inc | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9093 | ORIG | 2007-07-05 |