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): 018484
Company: PFIZER

Products on NDA 018484

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROSTIN VR PEDIATRIC	ALPROSTADIL	0.5MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018484

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/1981	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
07/18/2019	SUPPL-28	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018484Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018484Orig1s028ltr.pdf
06/09/2014	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
12/17/2002	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
05/01/2002	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
08/13/2001	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
04/03/2000	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
06/15/1994	SUPPL-12	Labeling		Label is not available on this site.
06/26/1993	SUPPL-11	Labeling		Label is not available on this site.
05/04/1994	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
01/26/1993	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
01/10/1995	SUPPL-8	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/11/1992	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
03/28/1990	SUPPL-6	Labeling		Label is not available on this site.
07/10/1987	SUPPL-5	Efficacy-New Dosing Regimen		Label is not available on this site.
04/14/1986	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
03/31/1988	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/28/1987	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
11/29/1982	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 018484

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2019	SUPPL-28	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018484Orig1s028lbl.pdf

Therapeutic Equivalents for NDA 018484

PROSTIN VR PEDIATRIC

INJECTABLE;INJECTION; 0.5MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALPROSTADIL	ALPROSTADIL	0.5MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	074815	HIKMA
ALPROSTADIL	ALPROSTADIL	0.5MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075196	TEVA PHARMS USA
PROSTIN VR PEDIATRIC	ALPROSTADIL	0.5MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018484	PFIZER

Top