Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017001
Company: BAUSCH
Company: BAUSCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ANCOBON | FLUCYTOSINE | 250MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| ANCOBON | FLUCYTOSINE | 500MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/26/1971 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/15/2022 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017001Orig1s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/017001Orig1s034ltr.pdf | |
| 02/12/2019 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017001s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017001Orig1s033ltr.pdf | |
| 11/08/2017 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017001s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017001Orig1s032ltr.pdf |
| 02/05/2016 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/2014 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/04/2009 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017001s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017001s028ltr.pdf | |
| 08/10/2006 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017001s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017001s027LTR.pdf | |
| 02/03/2000 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1999 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/27/1997 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/31/1997 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/2003 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/017001s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/170001slr019,020ltr.pdf | |
| 04/30/2003 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/017001s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/170001slr019,020ltr.pdf | |
| 08/08/1984 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/21/1983 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/06/1982 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/27/1982 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/01/1987 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 04/23/1981 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/26/1979 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/24/1978 | SUPPL-10 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/03/1978 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/11/1977 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/13/1977 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/15/2022 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017001Orig1s034lbl.pdf | |
| 02/12/2019 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017001s033lbl.pdf | |
| 11/08/2017 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017001s032lbl.pdf |
| 05/04/2009 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017001s028lbl.pdf | |
| 08/10/2006 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017001s027lbl.pdf | |
| 04/30/2003 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/017001s019lbl.pdf | |
| 04/30/2003 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/017001s019lbl.pdf |
ANCOBON
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 |