Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 062279
Company: VALEANT LUXEMBOURG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GRIFULVIN V GRISEOFULVIN, MICROCRYSTALLINE 125MG TABLET;ORAL Discontinued None No No
GRIFULVIN V GRISEOFULVIN, MICROCRYSTALLINE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
GRIFULVIN V GRISEOFULVIN, MICROSIZE 500MG TABLET;ORAL Discontinued None 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
06/02/1980 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/22/2014 SUPPL-22 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/062279s022lbl.pdf
08/08/1997 SUPPL-16 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/62483S013.pdf
02/16/1993 SUPPL-15 Labeling

Label is not available on this site.

01/27/1992 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/27/1992 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/22/1990 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/02/1990 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/17/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/27/1992 SUPPL-4 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
04/22/2014 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/062279s022lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English