Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 207624
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SEVELAMER CARBONATE | SEVELAMER CARBONATE | 800MG/PACKET | FOR SUSPENSION;ORAL | Prescription | AB | No | No |
| SEVELAMER CARBONATE | SEVELAMER CARBONATE | 2.4GM/PACKET | FOR SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 06/13/2017 | ORIG-1 | Approval | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207624Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207624Orig1s000ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/13/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207624Orig1s000lbl.pdf |
SEVELAMER CARBONATE
FOR SUSPENSION;ORAL; 800MG/PACKET
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RENVELA | SEVELAMER CARBONATE | 800MG/PACKET | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 022318 | GENZYME |
| SEVELAMER CARBONATE | SEVELAMER CARBONATE | 800MG/PACKET | FOR SUSPENSION;ORAL | Prescription | No | AB | 207624 | AUROBINDO PHARMA LTD |
| SEVELAMER CARBONATE | SEVELAMER CARBONATE | 800MG/PACKET | FOR SUSPENSION;ORAL | Prescription | No | AB | 210464 | DR REDDYS LABS LTD |
FOR SUSPENSION;ORAL; 2.4GM/PACKET
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RENVELA | SEVELAMER CARBONATE | 2.4GM/PACKET | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 022318 | GENZYME |
| SEVELAMER CARBONATE | SEVELAMER CARBONATE | 2.4GM/PACKET | FOR SUSPENSION;ORAL | Prescription | No | AB | 207624 | AUROBINDO PHARMA LTD |
| SEVELAMER CARBONATE | SEVELAMER CARBONATE | 2.4GM/PACKET | FOR SUSPENSION;ORAL | Prescription | No | AB | 210464 | DR REDDYS LABS LTD |
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