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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214842
Company: EUGIA PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POSACONAZOLE POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION;INTRAVENOUS 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
12/26/2023 ORIG-1 Approval STANDARD Letter (PDF)
Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214842Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214842Orig1s000TA_ltr.pdf

POSACONAZOLE

SOLUTION;INTRAVENOUS; 300MG/16.7ML (18MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NOXAFIL POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 205596 MERCK SHARP DOHME
POSACONAZOLE POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 214842 EUGIA PHARMA
POSACONAZOLE POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 209983 FRESENIUS KABI USA
POSACONAZOLE POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 217553 GLAND PHARMA LTD
POSACONAZOLE POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 211500 MYLAN LABS LTD
POSACONAZOLE POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 208768 PAR STERILE PRODUCTS
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