Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090877
Company: APOTEX
Company: APOTEX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
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 |
Label is not available on this site. |
||||
06/10/2014 | 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 |
---|---|---|---|---|---|
05/12/2023 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
12/15/2015 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
RISEDRONATE SODIUM
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 |
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 |
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 |
RISEDRONATE SODIUM | RISEDRONATE SODIUM | 75MG | TABLET;ORAL | Prescription | No | AB | 090886 | SUN PHARM |
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 |
RISEDRONATE SODIUM | RISEDRONATE SODIUM | 150MG | TABLET;ORAL | Prescription | No | AB | 206768 | AUROBINDO PHARMA |
RISEDRONATE SODIUM | RISEDRONATE SODIUM | 150MG | TABLET;ORAL | Prescription | No | AB | 090886 | SUN PHARM |
RISEDRONATE SODIUM | RISEDRONATE SODIUM | 150MG | TABLET;ORAL | Prescription | No | AB | 079215 | TEVA PHARMS USA |