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Application 209621
- Type
- ANDA
- Sponsor
- GLAND PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | INJECTABLE;INJECTION | EQ 10MG BASE/ML | No | No |
| 002 | TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | INJECTABLE;INJECTION | EQ 40MG BASE/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 68083-253 | Tobramycin | Tobramycin | Gland Pharma Limited | ANDA | Current |
| 68083-253 | Tobramycin | Tobramycin | Gland Pharma Limited | ANDA | Current |
| 68083-254 | Tobramycin | Tobramycin | Gland Pharma Limited | ANDA | Current |
| 68083-254 | Tobramycin | Tobramycin | Gland Pharma Limited | ANDA | Current |