Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018484
Company: PHARMACIA AND UPJOHN
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
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 Letter (PDF)

Label is not available on this site.

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.

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 075196 TEVA PHARMS USA
ALPROSTADIL ALPROSTADIL 0.5MG/ML INJECTABLE;INJECTION Prescription No AP 074815 WEST-WARD PHARMS INT
PROSTIN VR PEDIATRIC ALPROSTADIL 0.5MG/ML INJECTABLE;INJECTION Prescription Yes AP 018484 PHARMACIA AND UPJOHN

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