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Application 090022
- Type
- ANDA
- Sponsor
- SUN PHARM
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-1802 | Alendronate Sodium | Alendronate Sodium | A-S Medication Solutions | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 44414 | ORIG | 2008-09-19 |