Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205332
Company: AUROBINDO PHARMA 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
08/19/2015 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205332Orig1s000ltr.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
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 INC
IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE;INTRAVENOUS Prescription No AP 090853 SUN PHARM

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