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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203533
Company: MACLEODS PHARMS LTD
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/29/2016 ORIG-2 Approval

Label is not available on this site.

12/09/2015 ORIG-1 Approval

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
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 090886 SUN PHARM
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
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 205280 ORBION PHARMS
RISEDRONATE SODIUM RISEDRONATE SODIUM 30MG TABLET;ORAL Prescription No AB 090886 SUN PHARM
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 205280 ORBION PHARMS
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription No AB 090886 SUN PHARM
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription No AB 077132 TEVA PHARMS USA
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