Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206100
Company: MACLEODS PHARMS LTD
Company: MACLEODS PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SEVELAMER CARBONATE | SEVELAMER CARBONATE | 800MG | 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 |
---|---|---|---|---|---|---|---|
04/19/2023 | 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 |
---|---|---|---|---|---|
04/10/2024 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
SEVELAMER CARBONATE
TABLET;ORAL; 800MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RENVELA | SEVELAMER CARBONATE | 800MG | TABLET;ORAL | Prescription | Yes | AB | 022127 | SANOFI |
SEVELAMER CARBONATE | SEVELAMER CARBONATE | 800MG | TABLET;ORAL | Prescription | No | AB | 207288 | AMNEAL PHARMS CO |
SEVELAMER CARBONATE | SEVELAMER CARBONATE | 800MG | TABLET;ORAL | Prescription | No | AB | 200959 | ARTHUR GRP |
SEVELAMER CARBONATE | SEVELAMER CARBONATE | 800MG | TABLET;ORAL | Prescription | No | AB | 207179 | AUROBINDO PHARMA |
SEVELAMER CARBONATE | SEVELAMER CARBONATE | 800MG | TABLET;ORAL | Prescription | No | AB | 206094 | DR REDDYS |
SEVELAMER CARBONATE | SEVELAMER CARBONATE | 800MG | TABLET;ORAL | Prescription | No | AB | 203860 | INVAGEN PHARMS |
SEVELAMER CARBONATE | SEVELAMER CARBONATE | 800MG | TABLET;ORAL | Prescription | No | AB | 206100 | MACLEODS PHARMS LTD |
SEVELAMER CARBONATE | SEVELAMER CARBONATE | 800MG | TABLET;ORAL | Prescription | No | AB | 215537 | MICRO LABS |
SEVELAMER CARBONATE | SEVELAMER CARBONATE | 800MG | TABLET;ORAL | Prescription | No | AB | 204451 | RISING |
SEVELAMER CARBONATE | SEVELAMER CARBONATE | 800MG | TABLET;ORAL | Prescription | No | AB | 211915 | STRIDES PHARMA |
SEVELAMER CARBONATE | SEVELAMER CARBONATE | 800MG | TABLET;ORAL | Prescription | No | AB | 207759 | ZYDUS PHARMS |