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Drugs@FDA: FDA-Approved Drugs

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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
12/22/2025	SUPPL-30	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/018484s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/018484Orig1s030ltr.pdf
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
12/22/2025	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/018484s030lbl.pdf
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	MEITHEAL
PROSTIN VR PEDIATRIC	ALPROSTADIL	0.5MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018484	PFIZER

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