Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050509
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYCLAPEN-W CYCLACILLIN 250MG TABLET;ORAL Discontinued None No No
CYCLAPEN-W CYCLACILLIN 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
09/13/1979 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/08/1982 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

03/08/1982 SUPPL-10 Labeling

Label is not available on this site.

04/30/1980 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/07/1980 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

10/30/1979 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/1979 SUPPL-6 Labeling

Label is not available on this site.

01/20/1987 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

10/09/1985 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/12/1985 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/24/1984 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

02/13/1984 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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