Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203231
Company: INFORLIFE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/100ML 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
08/02/2013 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203231s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203231Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203231Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203231Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/02/2017 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203231s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203231Orig1s013ltr.pdf
03/25/2016 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203231s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203231Orig1s011ltr.pdf
10/08/2015 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203231s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203231Orig1s010ltr.pdf
08/31/2015 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/31/2015 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/10/2014 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s005s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203231Orig1s005,s006,s007ltr.pdf
12/10/2014 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s005s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203231Orig1s005,s006,s007ltr.pdf
12/10/2014 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s005s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203231Orig1s005,s006,s007ltr.pdf
03/11/2014 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/02/2014 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203231Orig1s002ltr.pdf
02/07/2014 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/02/2017 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203231s013lbl.pdf
03/25/2016 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203231s011lbl.pdf
10/08/2015 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203231s010lbl.pdf
12/10/2014 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s005s006s007lbl.pdf
12/10/2014 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s005s006s007lbl.pdf
12/10/2014 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s005s006s007lbl.pdf
05/02/2014 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s002lbl.pdf
08/02/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203231s000lbl.pdf

ZOLEDRONIC ACID

INJECTABLE;INTRAVENOUS; EQ 4MG BASE/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ZOLEDRONIC ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription No AP 205749 GLAND PHARMA LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription No AP 210174 CIPLA
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription No AP 204344 DR REDDYS LABS LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription No AP 203231 INFORLIFE
ZOMETA ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription Yes AP 021223 NOVARTIS

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