Application 078520
- Type
- ANDA
- Sponsor
- MYLAN LABS LTD
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67457-430 | Pamidronate Disodium | Pamidronate Disodium | Mylan Institutional LLC | ANDA | Current |
| 67457-446 | Pamidronate Disodium | Pamidronate Disodium | Mylan Institutional LLC | ANDA | Current |
| 82449-800 | Pamidronate Disodium | Pamidronate Disodium | Steriscience Specialties Private Limited | ANDA | Current |
| 82449-801 | Pamidronate Disodium | Pamidronate Disodium | Steriscience Specialties Private Limited | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23912 | ORIG | 2008-11-25 |