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Application 215687
- Type
- ANDA
- Sponsor
- GLAND PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MITOMYCIN | MITOMYCIN | INJECTABLE;INJECTION | 5MG/VIAL | No | No |
| 002 | MITOMYCIN | MITOMYCIN | INJECTABLE;INJECTION | 20MG/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 68083-483 | MITOMYCIN | MITOMYCIN | Gland Pharma Limited | ANDA | Current |
| 68083-484 | MITOMYCIN | MITOMYCIN | Gland Pharma Limited | ANDA | Current |