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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076870
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALLOPURINOL SODIUM ALLOPURINOL SODIUM EQ 500MG BASE/VIAL 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
08/26/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76870ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/09/2016 SUPPL-9 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

ALLOPURINOL SODIUM

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALLOPURINOL SODIUM ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 076870 HIKMA
ALOPRIM ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 020298 MYLAN
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