Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050051
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GRISACTIN GRISEOFULVIN, MICROCRYSTALLINE 250MG CAPSULE;ORAL Discontinued None No No
GRISACTIN GRISEOFULVIN, MICROCRYSTALLINE 125MG CAPSULE;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
08/22/1962 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
05/09/1996 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

05/26/1981 SUPPL-64 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1981 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

02/19/1981 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

12/31/1980 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

08/27/1980 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

06/24/1980 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

01/21/1980 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

11/08/1979 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

11/08/1979 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/1978 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

06/21/1977 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

06/10/1977 SUPPL-53 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/29/1976 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

10/16/1974 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

05/13/1976 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

04/01/1976 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

11/11/1975 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1975 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

06/05/1974 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/1974 SUPPL-45 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/22/1974 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/12/1973 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

02/02/1973 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

06/16/1972 SUPPL-41 Labeling

Label is not available on this site.

05/03/1972 SUPPL-40 Labeling

Label is not available on this site.

03/27/1972 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

02/03/1972 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/20/1972 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

11/12/1971 SUPPL-35 Labeling

Label is not available on this site.

09/13/1971 SUPPL-34 Labeling

Label is not available on this site.

06/28/1971 SUPPL-33 Labeling

Label is not available on this site.

06/03/1971 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/29/1969 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

07/15/1969 SUPPL-30 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/15/1969 SUPPL-29 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/24/1969 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

07/27/1967 SUPPL-27 Labeling

Label is not available on this site.

10/28/1966 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

09/27/1966 SUPPL-24 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/16/1966 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1966 SUPPL-22 Labeling

Label is not available on this site.

05/02/1966 SUPPL-21 Labeling

Label is not available on this site.

05/02/1966 SUPPL-20 Labeling

Label is not available on this site.

03/18/1966 SUPPL-19 Labeling

Label is not available on this site.

03/15/1966 SUPPL-18 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/14/1966 SUPPL-17 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/07/1966 SUPPL-16 Labeling

Label is not available on this site.

11/02/1965 SUPPL-15 Labeling

Label is not available on this site.

04/26/1965 SUPPL-14 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/24/1964 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/21/1964 SUPPL-11 Labeling

Label is not available on this site.

06/24/1964 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/16/1965 SUPPL-9 Labeling

Label is not available on this site.

08/04/1964 SUPPL-7 Labeling

Label is not available on this site.

01/28/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/29/1987 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/12/1984 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1983 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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