Application 201566
- Type
- ANDA
- Sponsor
- SIGMAPHARM LABS LLC
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 |
|---|
| 42794-009 | Flucytosine | Flucytosine | Sigmapharm Laboratories, | ANDA | Current |
| 42794-009 | Flucytosine | Flucytosine | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-009 | Flucytosine | Flucytosine | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-009 | Flucytosine | Flucytosine | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-010 | Flucytosine | Flucytosine | Sigmapharm Laboratories, | ANDA | Current |
| 42794-010 | Flucytosine | Flucytosine | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-010 | Flucytosine | Flucytosine | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-010 | Flucytosine | Flucytosine | Sigmapharm Laboratories, LLC | ANDA | Current |
| 64980-179 | Flucytosine | Flucytosine | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-180 | Flucytosine | Flucytosine | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 68151-0084 | Flucytosine | Flucytosine | Carilion Materials Management | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 32118 | ORIG | 2011-07-05 |