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Drugs@FDA: FDA-Approved Drugs

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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.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/19/2020 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

06/19/2020 SUPPL-20 Labeling-Container/Carton Labels

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 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
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