Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017810
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROSTIN E2 DINOPROSTONE 20MG SUPPOSITORY;VAGINAL 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
08/23/1977 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/05/2017 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017810s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017810Orig1s019ltr.pdf
05/29/2013 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

08/05/1997 SUPPL-16 Labeling

Label is not available on this site.

11/19/1997 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

02/19/1997 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

05/01/1991 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/08/1992 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1988 SUPPL-11 Labeling

Label is not available on this site.

06/23/1987 SUPPL-10 Labeling

Label is not available on this site.

09/08/1986 SUPPL-9 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/29/1986 SUPPL-8 Labeling

Label is not available on this site.

03/02/1982 SUPPL-7 Labeling

Label is not available on this site.

03/20/1980 SUPPL-6 Labeling

Label is not available on this site.

03/12/1979 SUPPL-4 Labeling

Label is not available on this site.

08/04/1978 SUPPL-3 Labeling

Label is not available on this site.

01/18/1978 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/05/2017 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017810s019lbl.pdf

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