Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201566
Company: SIGMAPHARM LABS LLC
Company: SIGMAPHARM LABS LLC
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 |
---|---|---|---|---|---|---|---|
06/28/2011 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201566s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/26/2022 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
10/26/2022 | SUPPL-4 | Labeling-Package Insert |
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 | 204652 | NOVEL LABS INC |
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 | 204652 | NOVEL LABS INC |
FLUCYTOSINE | FLUCYTOSINE | 500MG | CAPSULE;ORAL | Prescription | No | AB | 201566 | SIGMAPHARM LABS LLC |
FLUCYTOSINE | FLUCYTOSINE | 500MG | CAPSULE;ORAL | Prescription | No | AB | 212632 | STRIDES PHARMA |