Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050508
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYCLAPEN-W CYCLACILLIN 125MG/5ML FOR SUSPENSION;ORAL Discontinued None No No
CYCLAPEN-W CYCLACILLIN 250MG/5ML FOR SUSPENSION;ORAL Discontinued None No No
CYCLAPEN-W CYCLACILLIN 500MG/5ML FOR 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
09/14/1979 ORIG-1 Approval Type 1 - New Molecular Entity 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
08/17/1982 SUPPL-15 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/04/1982 SUPPL-14 Labeling

Label is not available on this site.

07/08/1982 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/27/1982 SUPPL-12 Labeling

Label is not available on this site.

03/08/1982 SUPPL-11 Labeling

Label is not available on this site.

02/04/1982 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

03/08/1982 SUPPL-9 Labeling

Label is not available on this site.

11/28/1980 SUPPL-8 Labeling

Label is not available on this site.

09/25/1980 SUPPL-7 Labeling

Label is not available on this site.

04/22/1980 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/30/1979 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/1979 SUPPL-4 Labeling

Label is not available on this site.

08/12/1985 SUPPL-3 Labeling

Label is not available on this site.

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

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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