Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075196
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALPROSTADIL ALPROSTADIL 0.5MG/ML INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/30/1999 ORIG-1 Approval

Label is not available on this site.

ALPROSTADIL

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

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