Application 213665
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FLUCYTOSINE | FLUCYTOSINE | CAPSULE;ORAL | 250MG | No | No |
| 002 | FLUCYTOSINE | FLUCYTOSINE | CAPSULE;ORAL | 500MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59651-331 | FLUCYTOSINE | FLUCYTOSINE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-331 | FLUCYTOSINE | FLUCYTOSINE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-331 | FLUCYTOSINE | FLUCYTOSINE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-331 | FLUCYTOSINE | FLUCYTOSINE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-332 | FLUCYTOSINE | FLUCYTOSINE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-332 | FLUCYTOSINE | FLUCYTOSINE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-332 | FLUCYTOSINE | FLUCYTOSINE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-332 | FLUCYTOSINE | FLUCYTOSINE | Aurobindo Pharma Limited | ANDA | Current |
| 60687-599 | FLUCYTOSINE | FLUCYTOSINE | American Health Packaging | ANDA | Current |
| 60687-599 | Flucytosine | Flucytosine | American Health Packaging | ANDA | Current |
| 60687-610 | FLUCYTOSINE | FLUCYTOSINE | American Health Packaging | ANDA | Current |
| 60687-610 | Flucytosine | Flucytosine | American Health Packaging | ANDA | Current |