Application 020927
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AREDIA | PAMIDRONATE DISODIUM | INJECTABLE; INJECTION | 30MG/VIAL | No | No |
| 002 | AREDIA | PAMIDRONATE DISODIUM | INJECTABLE;INJECTION | 60MG/VIAL | No | No |
| 003 | AREDIA | PAMIDRONATE DISODIUM | INJECTABLE; INJECTION | 90MG/VIAL | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Pamidronate Disodium | PAMIDRONATE DISODIUM | Hospira, Inc. | 9b6a9a3b-71c9-4dcb-b857-5d1de25c3a23 | 2026-05-14 | Warnings, Adverse reactions | PAMIDRONATE DISODIUM |
| Pamidronate Disodium | PAMIDRONATE DISODIUM | Mylan Institutional LLC | c2ca033e-fa5f-4141-b702-11f8b4303da1 | 2025-12-15 | Warnings, Adverse reactions | PAMIDRONATE DISODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.