Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017001
Company: VALEANT
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
11/08/2017 SUPPL-32 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

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
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 VALEANT
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 206550 WEST-WARD PHARMS INT

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 VALEANT
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 206550 WEST-WARD PHARMS INT

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