Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062483
Company: VALEANT LUXEMBOURG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GRIFULVIN V GRISEOFULVIN, MICROSIZE 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SUSPENSION;ORAL Discontinued None No No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
01/26/1984 ORIG-1 Approval Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/062483_grifulvin-v_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/02/2015 SUPPL-21 Labeling

Label is not available on this site.

10/17/2002 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.

02/11/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/1998 SUPPL-15 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/62483s015.pdf
09/21/1998 SUPPL-14 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/62483s014.pdf
08/13/1997 SUPPL-13 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/62483S013.pdf
11/22/1995 SUPPL-12 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/62483s012.pdf
04/13/1993 SUPPL-11 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/62483s011.pdf
07/14/1992 SUPPL-10 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/62483s010.pdf
09/17/1991 SUPPL-9 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/62483s009.pdf
03/22/1990 SUPPL-8 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/62483s008.pdf
03/21/1997 SUPPL-7 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/62483s007.pdf
11/06/1995 SUPPL-6 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/62483s006.pdf
03/17/1994 SUPPL-5 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/62483s005.pdf
03/03/1992 SUPPL-4 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/62483S004.pdf
03/03/1991 SUPPL-3 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/62483S003.pdf
08/29/1994 SUPPL-2 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/62483S002.pdf
04/12/1990 SUPPL-1 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/62483S001.pdf

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