Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040312
Company: NOVO NORDISK INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INNOFEM ESTRADIOL 0.5MG TABLET;ORAL Discontinued None No No
INNOFEM ESTRADIOL 1MG TABLET;ORAL Discontinued None No No
INNOFEM ESTRADIOL 2MG 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
11/19/1999 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40312ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/40312_Innofem.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/15/2002 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

01/17/2001 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

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