Application 064054
- Type
- ANDA
- Sponsor
- ACP NIMBLE
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GENTAMICIN SULFATE | GENTAMICIN SULFATE | OINTMENT;TOPICAL | EQ 0.1% BASE | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0713-0682 | Gentamicin Sulfate | Gentamicin Sulfate | Cosette Pharmaceuticals, Inc. | ANDA | Current |
| 0713-0682 | Gentamicin Sulfate | Gentamicin Sulfate | Cosette Pharmaceuticals, Inc. | ANDA | Current |
| 0713-0682 | Gentamicin Sulfate | Gentamicin Sulfate | Cosette Pharmaceuticals, Inc. | ANDA | Current |
| 0713-0682 | Gentamicin Sulfate | Gentamicin Sulfate | G&W Laboratories, Inc. | ANDA | Current |
| 71205-560 | Gentamicin Sulfate | Gentamicin Sulfate | Proficient Rx LP | ANDA | Current |