Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209374
Company: BIONPHARMA
Company: BIONPHARMA
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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/17/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/07/2022 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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 |
SEVELAMER CARBONATE | SEVELAMER CARBONATE | 800MG/PACKET | FOR SUSPENSION;ORAL | Prescription | No | AB | 209374 | BIONPHARMA |
SEVELAMER CARBONATE | SEVELAMER CARBONATE | 800MG/PACKET | FOR SUSPENSION;ORAL | Prescription | No | AB | 217319 | CHARTWELL RX |
SEVELAMER CARBONATE | SEVELAMER CARBONATE | 800MG/PACKET | FOR SUSPENSION;ORAL | Prescription | No | AB | 210464 | DR REDDYS |
SEVELAMER CARBONATE | SEVELAMER CARBONATE | 800MG/PACKET | FOR SUSPENSION;ORAL | Prescription | No | AB | 211316 | IMPAX |
SEVELAMER CARBONATE | SEVELAMER CARBONATE | 800MG/PACKET | FOR SUSPENSION;ORAL | Prescription | No | AB | 206234 | INVAGEN PHARMS |
SEVELAMER CARBONATE | SEVELAMER CARBONATE | 800MG/PACKET | FOR SUSPENSION;ORAL | Prescription | No | AB | 207291 | MACLEODS PHARMS LTD |
SEVELAMER CARBONATE | SEVELAMER CARBONATE | 800MG/PACKET | FOR SUSPENSION;ORAL | Prescription | No | AB | 211917 | STRIDES PHARMA |