Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 090978
Company: NATCO PHARMA LTD
Company: NATCO PHARMA LTD
| 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 |
|---|---|---|---|---|---|---|---|
| 08/11/2017 | 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 | SHIRE LLC |
| 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 | SHIRE LLC |
| 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 | SHIRE LLC |
| LANTHANUM CARBONATE | LANTHANUM CARBONATE | EQ 1GM BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 090978 | NATCO PHARMA LTD |
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