Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203217
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
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 |
---|---|---|---|---|---|---|---|
05/18/2015 | ORIG-1 | Approval |
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 |