Skip to contentApplication 078998
- Type
- ANDA
- Sponsor
- ORCHID HLTHCARE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IBANDRONATE SODIUM | IBANDRONATE SODIUM | TABLET;ORAL | EQ 150MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 47781-103 | IBANDRONATE SODIUM | IBANDRONATE SODIUM | Alvogen Inc. | ANDA | Current |
| 47781-103 | IBANDRONATE SODIUM | IBANDRONATE SODIUM | Alvogen Inc. | ANDA | Current |
| 47781-103 | IBANDRONATE SODIUM | IBANDRONATE SODIUM | Alvogen Inc. | ANDA | Current |
| 47781-103 | IBANDRONATE SODIUM | IBANDRONATE SODIUM | Alvogen Inc. | ANDA | Current |
| 47781-103 | IBANDRONATE SODIUM | IBANDRONATE SODIUM | Alvogen Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 43153 | ORIG | 2012-05-09 |
| 43154 | ORIG | 2012-04-13 |