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Abbreviated New Drug Application (ANDA): 208768
Company: PH HEALTH

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
05/25/2022 ORIG-1 Approval STANDARD Letter (PDF)
Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208768Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208768Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/02/2025 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

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
POSACONAZOLE POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 219057 ASPIRO
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
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 PH HEALTH
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