Application 205332
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IBANDRONATE SODIUM | IBANDRONATE SODIUM | INJECTABLE;INTRAVENOUS | EQ 3MG BASE/3ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55150-191 | Ibandronate Sodium | Ibandronate Sodium | AuroMedics Pharma LLC | ANDA | Current |
| 55150-191 | Ibandronate Sodium | Ibandronate Sodium | AuroMedics Pharma LLC | ANDA | Current |
| 55150-191 | Ibandronate Sodium | Ibandronate Sodium | AuroMedics Pharma LLC | ANDA | Current |
| 55150-191 | Ibandronate Sodium | Ibandronate Sodium | AuroMedics Pharma LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 32652 | ORIG | 2015-08-21 |