Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213001
Company: GLAND PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FOSCARNET SODIUM FOSCARNET SODIUM 2.4GM/100ML 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
04/21/2021 ORIG-1 Approval STANDARD Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213001Orig1s000ltr.pdf

FOSCARNET SODIUM

INJECTABLE;INJECTION; 2.4GM/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FOSCARNET SODIUM FOSCARNET SODIUM 2.4GM/100ML INJECTABLE;INJECTION Prescription No AP 212483 FRESENIUS KABI USA
FOSCARNET SODIUM FOSCARNET SODIUM 2.4GM/100ML INJECTABLE;INJECTION Prescription No AP 213001 GLAND PHARMA LTD
FOSCAVIR FOSCARNET SODIUM 2.4GM/100ML INJECTABLE;INJECTION Prescription Yes AP 020068 CLINIGEN HLTHCARE

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