Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090977
Company: BARR
Company: BARR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LANTHANUM CARBONATE | LANTHANUM CARBONATE | EQ 500MG BASE | TABLET, CHEWABLE;ORAL | Prescription | AB | No | No |
LANTHANUM CARBONATE | LANTHANUM CARBONATE | EQ 750MG BASE | TABLET, CHEWABLE;ORAL | Prescription | AB | No | No |
LANTHANUM CARBONATE | LANTHANUM CARBONATE | EQ 1GM BASE | TABLET, CHEWABLE;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 |
---|---|---|---|---|---|---|---|
01/27/2022 | ORIG-1 | Approval |
Label is not available on this site. |
LANTHANUM CARBONATE
TABLET, CHEWABLE;ORAL; EQ 500MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FOSRENOL | LANTHANUM CARBONATE | EQ 500MG BASE | TABLET, CHEWABLE;ORAL | Prescription | Yes | AB | 021468 | TAKEDA PHARMS USA |
LANTHANUM CARBONATE | LANTHANUM CARBONATE | EQ 500MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 090977 | BARR |
LANTHANUM CARBONATE | LANTHANUM CARBONATE | EQ 500MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 206868 | INVAGEN PHARMS |
LANTHANUM CARBONATE | LANTHANUM CARBONATE | EQ 500MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 090978 | NATCO PHARMA LTD |
TABLET, CHEWABLE;ORAL; EQ 750MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FOSRENOL | LANTHANUM CARBONATE | EQ 750MG BASE | TABLET, CHEWABLE;ORAL | Prescription | Yes | AB | 021468 | TAKEDA PHARMS USA |
LANTHANUM CARBONATE | LANTHANUM CARBONATE | EQ 750MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 090977 | BARR |
LANTHANUM CARBONATE | LANTHANUM CARBONATE | EQ 750MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 206868 | INVAGEN PHARMS |
LANTHANUM CARBONATE | LANTHANUM CARBONATE | EQ 750MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 090978 | NATCO PHARMA LTD |
TABLET, CHEWABLE;ORAL; EQ 1GM BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FOSRENOL | LANTHANUM CARBONATE | EQ 1GM BASE | TABLET, CHEWABLE;ORAL | Prescription | Yes | AB | 021468 | TAKEDA PHARMS USA |
LANTHANUM CARBONATE | LANTHANUM CARBONATE | EQ 1GM BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 090977 | BARR |
LANTHANUM CARBONATE | LANTHANUM CARBONATE | EQ 1GM BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 206868 | INVAGEN PHARMS |
LANTHANUM CARBONATE | LANTHANUM CARBONATE | EQ 1GM BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 090978 | NATCO PHARMA LTD |