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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209113
Company: ZYDUS PHARMS

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
09/14/2017 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209113Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209113Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/03/2023 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
07/03/2023 SUPPL-10 Labeling-Package Insert

Label is not available on this site.
12/03/2019 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
12/03/2019 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
12/03/2019 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
09/14/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209113Orig1s000lbl.pdf

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 212858 APTAPHARMA INC
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 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 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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