Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078996
Company: SUN PHARM INDUSTRIES
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
08/15/2012 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/22/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

07/22/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

07/22/2015 SUPPL-1 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 078996 SUN PHARM INDUSTRIES
IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 150MG BASE TABLET;ORAL Prescription No AB 079003 WATSON LABS TEVA

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