Application 076207
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | INJECTABLE;INJECTION | 30MG/10ML (3MG/ML) | No | No |
| 002 | PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | INJECTABLE;INJECTION | 90MG/10ML (9MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-735 | Pamidronate Disodium | PAMIDRONATE DISODIUM | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 44294 | ORIG | 2008-01-07 |