Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083220
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OGEN .625 ESTROPIPATE 0.75MG TABLET;ORAL Discontinued None No No
OGEN 1.25 ESTROPIPATE 1.5MG TABLET;ORAL Discontinued None No No
OGEN 2.5 ESTROPIPATE 3MG TABLET;ORAL Discontinued None No No
OGEN 5 ESTROPIPATE 6MG TABLET;ORAL Prescription 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
05/19/1977 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/03/2019 SUPPL-44 Labeling-Package Insert

Label is not available on this site.

11/03/2015 SUPPL-42 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

06/09/2005 SUPPL-41 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/083220s041lbl.pdf
09/26/2001 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/26/2001 SUPPL-38 Manufacturing (CMC)-Facility

Label is not available on this site.

04/20/1998 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

04/09/1998 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

07/17/1998 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

09/23/1997 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

06/24/1991 SUPPL-31 Bioequivalence

Label is not available on this site.

04/30/1992 SUPPL-25 Labeling

Label is not available on this site.

11/10/1992 SUPPL-24 Labeling

Label is not available on this site.

06/01/1987 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/30/1992 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/30/1992 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/11/1986 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/29/1985 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/26/1985 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/11/1984 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/04/1984 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/29/1985 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/09/2005 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/083220s041lbl.pdf

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