Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213665
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUCYTOSINE | FLUCYTOSINE | 250MG | CAPSULE;ORAL | Prescription | AB | No | No |
| FLUCYTOSINE | FLUCYTOSINE | 500MG | CAPSULE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/01/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
FLUCYTOSINE
CAPSULE;ORAL; 250MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ANCOBON | FLUCYTOSINE | 250MG | CAPSULE;ORAL | Prescription | Yes | AB | 017001 | BAUSCH |
| FLUCYTOSINE | FLUCYTOSINE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 213665 | AUROBINDO PHARMA LTD |
| FLUCYTOSINE | FLUCYTOSINE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 206550 | HIKMA |
| FLUCYTOSINE | FLUCYTOSINE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 204652 | NOVEL LABS INC |
| FLUCYTOSINE | FLUCYTOSINE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 207536 | RECIPHARM |
| FLUCYTOSINE | FLUCYTOSINE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 201566 | SIGMAPHARM LABS LLC |
| FLUCYTOSINE | FLUCYTOSINE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 212632 | STRIDES PHARMA |
CAPSULE;ORAL; 500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ANCOBON | FLUCYTOSINE | 500MG | CAPSULE;ORAL | Prescription | Yes | AB | 017001 | BAUSCH |
| FLUCYTOSINE | FLUCYTOSINE | 500MG | CAPSULE;ORAL | Prescription | No | AB | 213665 | AUROBINDO PHARMA LTD |
| FLUCYTOSINE | FLUCYTOSINE | 500MG | CAPSULE;ORAL | Prescription | No | AB | 206550 | HIKMA |
| FLUCYTOSINE | FLUCYTOSINE | 500MG | CAPSULE;ORAL | Prescription | No | AB | 204652 | NOVEL LABS INC |
| FLUCYTOSINE | FLUCYTOSINE | 500MG | CAPSULE;ORAL | Prescription | No | AB | 207536 | RECIPHARM |
| FLUCYTOSINE | FLUCYTOSINE | 500MG | CAPSULE;ORAL | Prescription | No | AB | 201566 | SIGMAPHARM LABS LLC |
| FLUCYTOSINE | FLUCYTOSINE | 500MG | CAPSULE;ORAL | Prescription | No | AB | 212632 | STRIDES PHARMA |
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