Application 201022
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FAMCICLOVIR | FAMCICLOVIR | TABLET;ORAL | 125MG | No | No |
| 002 | FAMCICLOVIR | FAMCICLOVIR | TABLET;ORAL | 250MG | No | No |
| 003 | FAMCICLOVIR | FAMCICLOVIR | TABLET;ORAL | 500MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 33342-024 | Famciclovir | Famciclovir | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-024 | Famciclovir | Famciclovir | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-024 | Famciclovir | Famciclovir | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-024 | Famciclovir | Famciclovir | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-025 | Famciclovir | Famciclovir | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-025 | Famciclovir | Famciclovir | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-025 | Famciclovir | Famciclovir | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-025 | Famciclovir | Famciclovir | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-026 | Famciclovir | Famciclovir | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-026 | Famciclovir | Famciclovir | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-026 | Famciclovir | Famciclovir | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-026 | Famciclovir | Famciclovir | Macleods Pharmaceuticals Limited | ANDA | Current |
| 71205-609 | Famciclovir | Famciclovir | Proficient Rx LP | ANDA | Current |