Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090836
Company: ALKEM LABS LTD
Company: ALKEM LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
CEPHALEXIN | CEPHALEXIN | EQ 333MG BASE | CAPSULE;ORAL | Prescription | None | No | No |
CEPHALEXIN | CEPHALEXIN | EQ 750MG BASE | CAPSULE;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 |
---|---|---|---|---|---|---|---|
12/20/2010 | 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 |
---|---|---|---|---|---|
10/10/2016 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
08/02/2013 | SUPPL-4 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
09/29/2011 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
CEPHALEXIN
CAPSULE;ORAL; EQ 250MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090836 | ALKEM LABS LTD |
CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065248 | ANDA REPOSITORY |
CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065253 | AUROBINDO PHARMA |
CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062713 | BELCHER PHARMS |
CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065152 | CHARTWELL RX |
CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065229 | LUPIN |
CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062702 | TEVA |
CAPSULE;ORAL; EQ 500MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090836 | ALKEM LABS LTD |
CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065248 | ANDA REPOSITORY |
CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065253 | AUROBINDO PHARMA |
CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062713 | BELCHER PHARMS |
CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065152 | CHARTWELL RX |
CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065229 | LUPIN |
CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062702 | TEVA |
CAPSULE;ORAL; EQ 750MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CEPHALEXIN | CEPHALEXIN | EQ 750MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090836 | ALKEM LABS LTD |
CEPHALEXIN | CEPHALEXIN | EQ 750MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065253 | AUROBINDO PHARMA |