Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018045
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EMCYT ESTRAMUSTINE PHOSPHATE SODIUM EQ 140MG PHOSPHATE CAPSULE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/24/1981 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
02/14/2013 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

07/09/2008 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018045s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018045s023ltr.pdf
10/28/2003 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18045slr021_emcyt_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18045slr021ltr.pdf
09/07/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

02/10/1999 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/10/1999 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/15/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/18/2002 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18045s16ltr.pdf
01/11/1996 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1995 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

01/25/1994 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

10/09/1998 SUPPL-10 Labeling

Label is not available on this site.

02/18/1994 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/05/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/16/1994 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/28/1993 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/17/1987 SUPPL-5 Labeling

Label is not available on this site.

10/22/1984 SUPPL-4 Labeling

Label is not available on this site.

04/25/1986 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/30/1982 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/09/2008 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018045s023lbl.pdf
10/28/2003 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18045slr021_emcyt_lbl.pdf

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