Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 019617
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREPIDIL DINOPROSTONE 0.5MG/3GM GEL;ENDOCERVICAL 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
12/09/1992 ORIG-1 Approval Type 3 - New Dosage Form 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
02/03/2015 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/05/2017 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019617s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019617Orig1s017ltr.pdf
09/10/2013 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/12/2010 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019617s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019617s010ltr.pdf
04/26/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/2001 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/13/1999 SUPPL-2 Labeling

Label is not available on this site.

02/27/1996 SUPPL-1 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-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019617s017lbl.pdf
02/12/2010 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019617s010lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English