Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200477
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RISEDRONATE SODIUM RISEDRONATE SODIUM 5MG TABLET;ORAL Prescription AB No No
RISEDRONATE SODIUM RISEDRONATE SODIUM 30MG TABLET;ORAL Prescription AB No No
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription AB No No
RISEDRONATE SODIUM RISEDRONATE SODIUM 75MG TABLET;ORAL Prescription AB No No
RISEDRONATE SODIUM RISEDRONATE SODIUM 150MG 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
11/30/2015 ORIG-2 Approval Not Applicable

Label is not available on this site.

06/10/2014 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/17/2015 SUPPL-2 Labeling-Medication Guide

Label is not available on this site.

RISEDRONATE SODIUM

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTONEL RISEDRONATE SODIUM 5MG TABLET;ORAL Prescription Yes AB 020835 APIL
RISEDRONATE SODIUM RISEDRONATE SODIUM 5MG TABLET;ORAL Prescription No AB 200296 AUROBINDO PHARMA LTD
RISEDRONATE SODIUM RISEDRONATE SODIUM 5MG TABLET;ORAL Prescription No AB 203533 MACLEODS PHARMS LTD
RISEDRONATE SODIUM RISEDRONATE SODIUM 5MG TABLET;ORAL Prescription No AB 200477 MYLAN PHARMS INC
RISEDRONATE SODIUM RISEDRONATE SODIUM 5MG TABLET;ORAL Prescription No AB 090886 SUN PHARMA GLOBAL
RISEDRONATE SODIUM RISEDRONATE SODIUM 5MG TABLET;ORAL Prescription No AB 077132 TEVA PHARMS USA

TABLET;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTONEL RISEDRONATE SODIUM 30MG TABLET;ORAL Prescription Yes AB 020835 APIL
RISEDRONATE SODIUM RISEDRONATE SODIUM 30MG TABLET;ORAL Prescription No AB 200296 AUROBINDO PHARMA LTD
RISEDRONATE SODIUM RISEDRONATE SODIUM 30MG TABLET;ORAL Prescription No AB 203533 MACLEODS PHARMS LTD
RISEDRONATE SODIUM RISEDRONATE SODIUM 30MG TABLET;ORAL Prescription No AB 200477 MYLAN PHARMS INC
RISEDRONATE SODIUM RISEDRONATE SODIUM 30MG TABLET;ORAL Prescription No AB 090886 SUN PHARMA GLOBAL
RISEDRONATE SODIUM RISEDRONATE SODIUM 30MG TABLET;ORAL Prescription No AB 077132 TEVA PHARMS USA

TABLET;ORAL; 35MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTONEL RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription Yes AB 020835 APIL
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription No AB 090877 APOTEX INC
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription No AB 200296 AUROBINDO PHARMA LTD
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription No AB 203533 MACLEODS PHARMS LTD
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription No AB 200477 MYLAN PHARMS INC
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription No AB 090886 SUN PHARMA GLOBAL
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription No AB 077132 TEVA PHARMS USA

TABLET;ORAL; 75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RISEDRONATE SODIUM RISEDRONATE SODIUM 75MG TABLET;ORAL Prescription No AB 090877 APOTEX INC
RISEDRONATE SODIUM RISEDRONATE SODIUM 75MG TABLET;ORAL Prescription No AB 200477 MYLAN PHARMS INC
RISEDRONATE SODIUM RISEDRONATE SODIUM 75MG TABLET;ORAL Prescription No AB 090886 SUN PHARMA GLOBAL

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTONEL RISEDRONATE SODIUM 150MG TABLET;ORAL Prescription Yes AB 020835 APIL
RISEDRONATE SODIUM RISEDRONATE SODIUM 150MG TABLET;ORAL Prescription No AB 090877 APOTEX INC
RISEDRONATE SODIUM RISEDRONATE SODIUM 150MG TABLET;ORAL Prescription No AB 206768 AUROBINDO PHARMA LTD
RISEDRONATE SODIUM RISEDRONATE SODIUM 150MG TABLET;ORAL Prescription No AB 200477 MYLAN PHARMS INC
RISEDRONATE SODIUM RISEDRONATE SODIUM 150MG TABLET;ORAL Prescription No AB 090886 SUN PHARMA GLOBAL
RISEDRONATE SODIUM RISEDRONATE SODIUM 150MG TABLET;ORAL Prescription No AB 079215 TEVA PHARMS USA

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