Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090853
Company: SUN PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE;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
02/14/2014 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/090853Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/090853Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/02/2015 SUPPL-3 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/14/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/090853Orig1s000lbl.pdf

IBANDRONATE SODIUM

INJECTABLE;INTRAVENOUS; EQ 3MG BASE/3ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BONIVA IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE;INTRAVENOUS Prescription Yes AP 021858 ROCHE
IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE;INTRAVENOUS Prescription No AP 206058 ACCORD HLTHCARE
IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE;INTRAVENOUS Prescription No AP 204222 APOTEX INC
IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE;INTRAVENOUS Prescription No AP 205332 AUROBINDO PHARMA LTD
IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE;INTRAVENOUS Prescription No AP 203987 EMCURE PHARMS LTD
IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE;INTRAVENOUS Prescription No AP 202671 MYLAN LABS LTD
IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE;INTRAVENOUS Prescription No AP 202235 SAGENT PHARMS
IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE;INTRAVENOUS Prescription No AP 090853 SUN PHARM INDS LTD

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