Application 204632
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | TABLET;ORAL | 2.5MG | No | No |
| 002 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 003 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 004 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 33342-151 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-151 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-151 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-152 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-152 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-152 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-153 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-153 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-153 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-154 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-154 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-154 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 73750-102 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | QYK BRANDS LLC | ANDA | Current |
| 73750-102 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | QYK BRANDS LLC | ANDA | Current |
| 73750-103 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | QYK BRANDS LLC | ANDA | Current |
| 73750-103 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | QYK BRANDS LLC | ANDA | Current |
| 73750-104 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | QYK BRANDS LLC | ANDA | Current |
| 73750-104 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | QYK BRANDS LLC | ANDA | Current |
| 73750-105 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | QYK BRANDS LLC | ANDA | Current |
| 73750-105 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | QYK BRANDS LLC | ANDA | Current |