Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 005897
Company: WYETH PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FOLVITE FOLIC ACID 1MG TABLET;ORAL Discontinued None No No
FOLVITE FOLIC ACID 5MG/ML INJECTABLE;INJECTION 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
06/05/1947 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/10/1984 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

04/20/1984 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/1984 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/09/1981 SUPPL-22 Labeling

Label is not available on this site.

10/26/1979 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1979 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

12/13/1979 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1979 SUPPL-18 Labeling

Label is not available on this site.

01/10/1979 SUPPL-17 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/10/1979 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1979 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

05/13/1976 SUPPL-12 Unspecified

Label is not available on this site.

05/13/1976 SUPPL-11 Unspecified

Label is not available on this site.

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