Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050011
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PATHOCIL DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE;ORAL Discontinued None No No
PATHOCIL DICLOXACILLIN SODIUM EQ 500MG BASE 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
05/09/1968 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
02/28/1983 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

10/28/1982 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1982 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/1981 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

10/14/1980 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

10/02/1980 SUPPL-24 Labeling

Label is not available on this site.

09/19/1980 SUPPL-23 Labeling

Label is not available on this site.

04/24/1978 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1977 SUPPL-21 Labeling

Label is not available on this site.

01/27/1976 SUPPL-20 Labeling

Label is not available on this site.

08/15/1975 SUPPL-19 Labeling

Label is not available on this site.

05/30/1975 SUPPL-18 Labeling

Label is not available on this site.

04/11/1974 SUPPL-17 Labeling

Label is not available on this site.

04/01/1974 SUPPL-16 Labeling

Label is not available on this site.

03/20/1974 SUPPL-15 Labeling

Label is not available on this site.

02/22/1974 SUPPL-14 Labeling

Label is not available on this site.

02/22/1974 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/05/1973 SUPPL-12 Labeling

Label is not available on this site.

03/02/1973 SUPPL-11 Labeling

Label is not available on this site.

08/01/1972 SUPPL-10 Labeling

Label is not available on this site.

12/14/1970 SUPPL-9 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/01/1970 SUPPL-8 Labeling

Label is not available on this site.

09/26/1969 SUPPL-7 Labeling

Label is not available on this site.

07/01/1968 SUPPL-6 Labeling

Label is not available on this site.

06/05/1968 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/10/1991 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/16/1987 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/12/1985 SUPPL-2 Efficacy-New Dosing Regimen

Label is not available on this site.

03/28/1983 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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