Application 018976
- Type
- NDA
- Sponsor
- AUXILIUM PHARMS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LEVATOL | PENBUTOLOL SULFATE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | LEVATOL | PENBUTOLOL SULFATE | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 11400 | SUPPL | 2011-05-05 |