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Application 210574
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CEFIXIME | CEFIXIME | CAPSULE;ORAL | 400MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 67877-584 | CEFIXIME | CEFIXIME | Ascend Laboratories, LLC | ANDA | Current |
| 67877-584 | CEFIXIME | CEFIXIME | Ascend Laboratories, LLC | ANDA | Current |
| 67877-584 | CEFIXIME | CEFIXIME | Ascend Laboratories, LLC | ANDA | Current |
| 70518-2749 | CEFIXIME | CEFIXIME | REMEDYREPACK INC. | ANDA | Current |
| 70518-2749 | CEFIXIME | CEFIXIME | REMEDYREPACK INC. | ANDA | Current |
| 70518-2749 | CEFIXIME | CEFIXIME | REMEDYREPACK INC. | ANDA | Current |
| 70518-2749 | CEFIXIME | CEFIXIME | REMEDYREPACK INC. | ANDA | Current |
| 70518-2749 | CEFIXIME | CEFIXIME | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 56478 | ORIG | 2018-11-15 |