| Product NDC: | 43353-323 |
| Proprietary Name: | Levitra |
| Non Proprietary Name: | vardenafil hydrochloride |
| Active Ingredient(s): | 5 mg/1 & nbsp; vardenafil hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 43353-323 |
| Labeler Name: | APHENA PHARMA SOLUTIONS - TENNESSEE, INC. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021400 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20080515 |
| Package NDC: | 43353-323-02 |
| Package Description: | 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-323-02) |
| NDC Code | 43353-323-02 |
| Proprietary Name | Levitra |
| Package Description | 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-323-02) |
| Product NDC | 43353-323 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | vardenafil hydrochloride |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20080515 |
| Marketing Category Name | NDA |
| Labeler Name | APHENA PHARMA SOLUTIONS - TENNESSEE, INC. |
| Substance Name | VARDENAFIL HYDROCHLORIDE |
| Strength Number | 5 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] |