Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062438
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GRISACTIN ULTRA GRISEOFULVIN, ULTRAMICROCRYSTALLINE 165MG TABLET;ORAL Discontinued None No No
GRISACTIN ULTRA GRISEOFULVIN, ULTRAMICROCRYSTALLINE 330MG 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
11/17/1983 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
01/31/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/20/1991 SUPPL-10 Bioequivalence

Label is not available on this site.

03/27/1990 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/03/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/08/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/01/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

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