| Product NDC: | 0085-3099 |
| Proprietary Name: | Staxyn |
| Non Proprietary Name: | vardenafil hydrochloride |
| Active Ingredient(s): | 11.85 mg/1 & nbsp; vardenafil hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, ORALLY DISINTEGRATING |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0085-3099 |
| Labeler Name: | Schering Plough Corporation |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA200179 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20110412 |
| Package NDC: | 0085-3099-04 |
| Package Description: | 1 BLISTER PACK in 1 BOX (0085-3099-04) > 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
| NDC Code | 0085-3099-04 |
| Proprietary Name | Staxyn |
| Package Description | 1 BLISTER PACK in 1 BOX (0085-3099-04) > 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
| Product NDC | 0085-3099 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | vardenafil hydrochloride |
| Dosage Form Name | TABLET, ORALLY DISINTEGRATING |
| Route Name | ORAL |
| Start Marketing Date | 20110412 |
| Marketing Category Name | NDA |
| Labeler Name | Schering Plough Corporation |
| Substance Name | VARDENAFIL HYDROCHLORIDE |
| Strength Number | 11.85 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] |