Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022560
Company: APIL
Company: APIL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ATELVIA | RISEDRONATE SODIUM | 35MG | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/08/2010 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022560s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022560s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022560Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022560Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/18/2020 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022560s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022560Orig1s011ltr.pdf | |
04/08/2015 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022560s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022560Orig1s007ltr.pdf | |
03/26/2015 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022560s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022560Orig1s006ltr.pdf | |
04/19/2013 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022560s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022560Orig1s005ltr.pdf | |
08/13/2012 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022560s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022560Orig1s004ltr.pdf | |
08/22/2011 | SUPPL-3 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022560s003ltr.pdf |
01/25/2011 | SUPPL-2 | REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022560s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022560s001,s002ltr.pdf | |
01/25/2011 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022560s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022560s001,s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/18/2020 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022560s011lbl.pdf | |
04/08/2015 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022560s007lbl.pdf | |
03/26/2015 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022560s006lbl.pdf | |
04/19/2013 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022560s005lbl.pdf | |
08/13/2012 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022560s004lbl.pdf | |
01/25/2011 | SUPPL-2 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022560s001lbl.pdf | |
01/25/2011 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022560s001lbl.pdf | |
10/08/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022560s000lbl.pdf |
ATELVIA
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 |