Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065135
Company: LUPIN
Company: LUPIN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/25/2003 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/27/2022 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/19/2019 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/19/2019 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/18/2017 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/24/2016 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/24/2016 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/25/2015 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/18/2008 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 09/18/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 10/30/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/26/2005 | SUPPL-1 | Labeling |
Label is not available on this site. |
CEFUROXIME AXETIL
TABLET;ORAL; EQ 250MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 065496 | ALKEM LABS LTD |
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 065359 | ANDA REPOSITORY |
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 065069 | APOTEX |
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 065308 | AUROBINDO PHARMA |
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 065166 | CHARTWELL RX |
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 065135 | LUPIN |
TABLET;ORAL; EQ 500MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 065496 | ALKEM LABS LTD |
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 065359 | ANDA REPOSITORY |
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 065069 | APOTEX |
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 065308 | AUROBINDO PHARMA |
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 065166 | CHARTWELL RX |
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 065135 | LUPIN |