Application 076584
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALENDRONATE SODIUM | ALENDRONATE SODIUM | TABLET;ORAL | EQ 5MG BASE | No | No |
| 002 | ALENDRONATE SODIUM | ALENDRONATE SODIUM | TABLET;ORAL | EQ 10MG BASE | No | No |
| 003 | ALENDRONATE SODIUM | ALENDRONATE SODIUM | TABLET;ORAL | EQ 35MG BASE | No | No |
| 004 | ALENDRONATE SODIUM | ALENDRONATE SODIUM | TABLET;ORAL | EQ 70MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-3566 | Alendronate Sodium | alendronate sodium | Mylan Pharmaceuticals Inc | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44313 | ORIG | 2008-09-19 |