Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 211125
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription AB 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
02/27/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

OSELTAMIVIR PHOSPHATE

FOR SUSPENSION;ORAL; EQ 6MG BASE/ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription No AB 208823 ALVOGEN PINE BROOK
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription No AB 210186 AMNEAL PHARMS NY
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription No AB 208347 LUPIN ATLANTIS
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription No AB 209113 NESHER PHARMS
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription No AB 211125 TEVA PHARMS USA
TAMIFLU OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription Yes AB 021246 ROCHE

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