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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203925
Company: SUN PHARM

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET, DELAYED RELEASE;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
07/09/2019 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
12/18/2023 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

RISEDRONATE SODIUM

TABLET, DELAYED RELEASE;ORAL; 35MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATELVIA RISEDRONATE SODIUM 35MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 022560 APIL
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 203925 SUN PHARM
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 203217 TEVA PHARMS USA
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