Application 062366
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GENTAMICIN SULFATE | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 40MG BASE/ML | No | Yes |
| 002 | GENTAMICIN SULFATE | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 10MG BASE/ML | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0404-9866 | Gentamicin | Gentamicin Sulfate | Henry Schein, Inc | ANDA | Current |
| 0404-9866 | Gentamicin | Gentamicin Sulfate | Henry Schein, Inc | ANDA | Current |
| 51662-1508 | GENTAMICIN | GENTAMICIN | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1508 | GENTAMICIN | GENTAMICIN | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 52584-010 | Gentamicin | Gentamicin Sulfate | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-010 | Gentamicin | Gentamicin Sulfate | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-010 | Gentamicin | Gentamicin Sulfate | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-010 | Gentamicin | Gentamicin Sulfate | General Injectables & Vaccines, Inc | ANDA | Current |
| 63323-010 | Gentamicin | GENTAMICIN SULFATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-010 | Gentamicin | GENTAMICIN SULFATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-010 | Gentamicin | GENTAMICIN SULFATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-010 | Gentamicin | GENTAMICIN SULFATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-010 | Gentamicin | GENTAMICIN SULFATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-010 | Gentamicin | GENTAMICIN SULFATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-010 | Gentamicin | GENTAMICIN SULFATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-173 | Gentamicin | GENTAMICIN | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-173 | Gentamicin | GENTAMICIN | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-173 | Gentamicin | GENTAMICIN | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-173 | Gentamicin | GENTAMICIN | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-173 | Gentamicin | GENTAMICIN | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-173 | Gentamicin | GENTAMICIN | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-173 | Gentamicin | GENTAMICIN | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-173 | Gentamicin | GENTAMICIN | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 39398 | SUPPL | 2014-03-21 |