Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 010753
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESTRADURIN POLYESTRADIOL PHOSPHATE 40MG/AMP 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
04/17/1957 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
09/06/1990 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1989 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/14/1989 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/19/1985 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/01/1981 SUPPL-12 Efficacy

Label is not available on this site.

06/15/1981 SUPPL-11 Efficacy

Label is not available on this site.

12/13/1979 SUPPL-10 Efficacy

Label is not available on this site.

12/13/1979 SUPPL-9 Efficacy

Label is not available on this site.

12/13/1979 SUPPL-8 Efficacy

Label is not available on this site.

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