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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020298
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALOPRIM ALLOPURINOL SODIUM EQ 500MG BASE/VIAL 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
05/17/1996 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/16/2020 SUPPL-13 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020298Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020298Orig1s013ltr.pdf
02/17/2022 SUPPL-12 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020298s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020298Orig1s012ltr.pdf
08/28/2020 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020298s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020298Orig1s010ltr.pdf
05/13/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/09/2013 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/28/2000 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/2000 SUPPL-1 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/020298Orig1s001.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/17/2022 SUPPL-12 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020298s012lbl.pdf
02/17/2022 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020298s012lbl.pdf
12/16/2020 SUPPL-13 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020298Orig1s013lbl.pdf
12/16/2020 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020298Orig1s013lbl.pdf
08/28/2020 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020298s010lbl.pdf
05/12/2000 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/020298Orig1s001.pdf

ALOPRIM

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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