Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078997
Company: DR REDDYS LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 150MG BASE TABLET;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
04/30/2012 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/078997Orig1s000Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/15/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

07/15/2015 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

03/08/2013 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

IBANDRONATE SODIUM

TABLET;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BONIVA IBANDRONATE SODIUM EQ 150MG BASE TABLET;ORAL Prescription Yes AB 021455 HOFFMANN LA ROCHE
IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 150MG BASE TABLET;ORAL Prescription No AB 078948 APOTEX INC
IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 150MG BASE TABLET;ORAL Prescription No AB 204502 AUROBINDO PHARMA LTD
IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 150MG BASE TABLET;ORAL Prescription No AB 078997 DR REDDYS LABS LTD
IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 150MG BASE TABLET;ORAL Prescription No AB 206887 MACLEODS PHARMS LTD
IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 150MG BASE TABLET;ORAL Prescription No AB 078998 ORCHID HLTHCARE
IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 150MG BASE TABLET;ORAL Prescription No AB 079003 WATSON LABS TEVA

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