Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065496
Company: ALKEM LABS LTD
Company: ALKEM LABS LTD
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 | 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 |
---|---|---|---|---|---|---|---|
06/07/2010 | 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-15 | Labeling-Package Insert |
Label is not available on this site. |
||
12/19/2019 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
12/19/2019 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
03/10/2017 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
04/19/2017 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
03/24/2016 | SUPPL-4 | Labeling-Package Insert |
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 |