Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213145
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SEVELAMER HYDROCHLORIDE | SEVELAMER HYDROCHLORIDE | 400MG | TABLET;ORAL | Prescription | AB | No | No |
SEVELAMER HYDROCHLORIDE | SEVELAMER HYDROCHLORIDE | 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 |
---|---|---|---|---|---|---|---|
06/16/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
SEVELAMER HYDROCHLORIDE
TABLET;ORAL; 400MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RENAGEL | SEVELAMER HYDROCHLORIDE | 400MG | TABLET;ORAL | Prescription | Yes | AB | 021179 | GENZYME |
SEVELAMER HYDROCHLORIDE | SEVELAMER HYDROCHLORIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 212599 | AUROBINDO PHARMA LTD |
SEVELAMER HYDROCHLORIDE | SEVELAMER HYDROCHLORIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 204724 | GLENMARK PHARMS LTD |
SEVELAMER HYDROCHLORIDE | SEVELAMER HYDROCHLORIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 213145 | LUPIN LTD |
SEVELAMER HYDROCHLORIDE | SEVELAMER HYDROCHLORIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 206883 | MACLEODS PHARMS LTD |
TABLET;ORAL; 800MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RENAGEL | SEVELAMER HYDROCHLORIDE | 800MG | TABLET;ORAL | Prescription | Yes | AB | 021179 | GENZYME |
SEVELAMER HYDROCHLORIDE | SEVELAMER HYDROCHLORIDE | 800MG | TABLET;ORAL | Prescription | No | AB | 212599 | AUROBINDO PHARMA LTD |
SEVELAMER HYDROCHLORIDE | SEVELAMER HYDROCHLORIDE | 800MG | TABLET;ORAL | Prescription | No | AB | 204724 | GLENMARK PHARMS LTD |
SEVELAMER HYDROCHLORIDE | SEVELAMER HYDROCHLORIDE | 800MG | TABLET;ORAL | Prescription | No | AB | 213145 | LUPIN LTD |
SEVELAMER HYDROCHLORIDE | SEVELAMER HYDROCHLORIDE | 800MG | TABLET;ORAL | Prescription | No | AB | 206883 | MACLEODS PHARMS LTD |