Application 206141
- Type
- ANDA
- Sponsor
- GLAND PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MEROPENEM | MEROPENEM | INJECTABLE;INJECTION | 500MG/VIAL | No | No |
| 002 | MEROPENEM | MEROPENEM | INJECTABLE;INJECTION | 1GM/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68083-146 | Meropenem | Meropenem | Gland Pharma Limited | ANDA | Current |
| 68083-146 | Meropenem | Meropenem | Gland Pharma Limited | ANDA | Current |
| 68083-146 | Meropenem | Meropenem | Gland Pharma Limited | ANDA | Current |
| 68083-147 | Meropenem | Meropenem | Gland Pharma Limited | ANDA | Current |
| 68083-147 | Meropenem | Meropenem | Gland Pharma Limited | ANDA | Current |
| 68083-147 | Meropenem | Meropenem | Gland Pharma Limited | ANDA | Current |
| 70594-075 | MEROPENEM | MEROPENEM | Xellia Pharmaceuticals USA LLC | ANDA | Current |
| 70594-076 | MEROPENEM | MEROPENEM | Xellia Pharmaceuticals USA LLC | ANDA | Current |