Application 202571
- Type
- ANDA
- Sponsor
- BRECKENRIDGE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZOLEDRONIC ACID | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 4MG BASE/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42023-167 | Zoledronic Acid | Zoledronic Acid | JHP Pharmaceuticals, LLC. | ANDA | Current |
| 51991-065 | Zoledronic Acid | Zoledronic Acid | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 68001-366 | Zoledronic Acid | Zoledronic Acid | BluePoint Laboratories | ANDA | Current |