An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 017810
Company: PFIZER

Products on NDA 017810

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROSTIN E2	DINOPROSTONE	20MG	SUPPOSITORY;VAGINAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017810

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.

Labels for NDA 017810

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

Top