Application 078252
- Type
- ANDA
- Sponsor
- INFORLIFE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | CIPROFLOXACIN | INJECTABLE;INJECTION | 200MG/100ML | No | No |
| 002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | CIPROFLOXACIN | INJECTABLE;INJECTION | 400MG/200ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-2300 | Ciprofloxacin in Dextrose | ciprofloxacin | Hospira, Inc | ANDA | Current |
| 0409-3300 | Ciprofloxacin in Dextrose | ciprofloxacin | Hospira, Inc | ANDA | Current |
| 0781-3239 | Ciprofloxacin | Ciprofloxacin | Sandoz Inc | ANDA | Current |
| 0781-3240 | Ciprofloxacin | Ciprofloxacin | Sandoz Inc | ANDA | Current |
| 25021-114 | Ciprofloxacin | ciprofloxacin | Sagent Pharmaceuticals | ANDA | Current |
| 25021-114 | Ciprofloxacin | ciprofloxacin | Sagent Pharmaceuticals | ANDA | Current |
| 25021-114 | Ciprofloxacin | ciprofloxacin | Sagent Pharmaceuticals | ANDA | Current |
| 25021-114 | Ciprofloxacin | ciprofloxacin | Sagent Pharmaceuticals | ANDA | Current |
| 25021-114 | Ciprofloxacin | ciprofloxacin | Sagent Pharmaceuticals | ANDA | Current |
| 25021-192 | Ciprofloxacin | ciprofloxacin | Sagent Pharmaceuticals | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31351 | ORIG | 2008-03-19 |