Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074815
Company: WEST-WARD PHARMS INT
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
01/20/1998 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074815ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/11/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/2001 SUPPL-4 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

07/11/2000 SUPPL-3 Labeling

Label is not available on this site.

07/11/2000 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/11/2000 SUPPL-1 Manufacturing (CMC)-Packaging

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

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