Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050475
Company: VALEANT PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GRIS-PEG GRISEOFULVIN, ULTRAMICROSIZE 125MG TABLET;ORAL Prescription AB Yes No
GRIS-PEG GRISEOFULVIN, ULTRAMICROSIZE 250MG TABLET;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
04/16/1975 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/19/2016 SUPPL-57 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050475s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050475Orig1s057ltr.pdf
05/08/2013 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

10/19/2010 SUPPL-54 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050475s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050475s054ltr.pdf
01/24/2007 SUPPL-53 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050475s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050475s053ltr.pdf
08/01/2002 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/2002 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

07/02/2001 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

12/06/2000 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

04/16/1998 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/2003 SUPPL-46 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50475slr046_gris-peg_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50475slr046ltr.pdf
04/07/1997 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/1982 SUPPL-44 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/21/1982 SUPPL-43 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/28/1982 SUPPL-42 Labeling

Label is not available on this site.

02/05/1982 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

07/06/1981 SUPPL-37 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/05/1981 SUPPL-34 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/02/1981 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/13/1980 SUPPL-32 Labeling

Label is not available on this site.

11/21/1980 SUPPL-31 Labeling

Label is not available on this site.

01/04/1980 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

01/04/1980 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/21/1980 SUPPL-27 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/10/1979 SUPPL-25 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/21/1980 SUPPL-24 Labeling

Label is not available on this site.

01/17/1978 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1977 SUPPL-21 Labeling

Label is not available on this site.

04/20/1977 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/08/1976 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/18/1976 SUPPL-18 Labeling

Label is not available on this site.

11/18/1976 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1976 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/04/1976 SUPPL-15 Labeling

Label is not available on this site.

09/16/1976 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/01/1976 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/16/1976 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/1975 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/16/1975 SUPPL-9 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/20/1988 SUPPL-8 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/16/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/16/1985 SUPPL-5 Labeling

Label is not available on this site.

10/24/1984 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/24/1984 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/17/1983 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/26/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/19/2016 SUPPL-57 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050475s057lbl.pdf
10/19/2010 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050475s054lbl.pdf
01/24/2007 SUPPL-53 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050475s053lbl.pdf
03/26/2003 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50475slr046_gris-peg_lbl.pdf

GRIS-PEG

TABLET;ORAL; 125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GRIS-PEG GRISEOFULVIN, ULTRAMICROSIZE 125MG TABLET;ORAL Prescription Yes AB 050475 VALEANT PHARMS INC
GRISEOFULVIN, ULTRAMICROSIZE GRISEOFULVIN, ULTRAMICROSIZE 125MG TABLET;ORAL Prescription No AB 204371 MOUNTAIN
GRISEOFULVIN, ULTRAMICROSIZE GRISEOFULVIN, ULTRAMICROSIZE 125MG TABLET;ORAL Prescription No AB 202805 SANDOZ INC
GRISEOFULVIN,ULTRAMICROSIZE GRISEOFULVIN, ULTRAMICROSIZE 125MG TABLET;ORAL Prescription No AB 202545 SIGMAPHARM LABS LLC

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GRIS-PEG GRISEOFULVIN, ULTRAMICROSIZE 250MG TABLET;ORAL Prescription Yes AB 050475 VALEANT PHARMS INC
GRISEOFULVIN, ULTRAMICROSIZE GRISEOFULVIN, ULTRAMICROSIZE 250MG TABLET;ORAL Prescription No AB 204371 MOUNTAIN
GRISEOFULVIN, ULTRAMICROSIZE GRISEOFULVIN, ULTRAMICROSIZE 250MG TABLET;ORAL Prescription No AB 202805 SANDOZ INC
GRISEOFULVIN,ULTRAMICROSIZE GRISEOFULVIN, ULTRAMICROSIZE 250MG TABLET;ORAL Prescription No AB 202545 SIGMAPHARM LABS LLC

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