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Application 090031
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CEFPODOXIME PROXETIL | CEFPODOXIME PROXETIL | FOR SUSPENSION;ORAL | EQ 50MG BASE/5ML | No | No |
| 002 | CEFPODOXIME PROXETIL | CEFPODOXIME PROXETIL | FOR SUSPENSION;ORAL | EQ 100MG BASE/5ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0781-6168 | Cefpodoxime Proxetil | Cefpodoxime Proxetil | Sandoz Inc | ANDA | Current |
| 0781-6169 | Cefpodoxime Proxetil | Cefpodoxime Proxetil | Sandoz Inc | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 39607 | SUPPL | 2014-07-30 |
| 31441 | SUPPL | 2014-07-24 |