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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208823
Company: ALVOGEN

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
10/31/2017 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/16/2021 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.
12/16/2021 SUPPL-5 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.
12/16/2021 SUPPL-2 Labeling-Package Insert, Labeling-Patient Package Insert

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 212784 AJANTA PHARMA LTD
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription No AB 208823 ALVOGEN
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 218131 AUROBINDO PHARMA LTD
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription No AB 215538 EPIC PHARMA LLC
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription No AB 209590 HETERO LABS LTD V
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription No AB 212858 INVAGEN PHARMS
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription No AB 213695 JUBILANT GENERICS
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription No AB 208347 LUPIN
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription No AB 215313 MSN
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription No AB 217303 PHARMOBEDIENT
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription No AB 211894 STRIDES PHARMA
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription No AB 213594 SUNSHINE
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription No AB 211125 TEVA PHARMS USA
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription No AB 209113 ZYDUS PHARMS
TAMIFLU OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription Yes AB 021246 ROCHE
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