CEPHALEXIN از شرکت ALKEM LABS LTD

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

CEPHALEXIN از شرکت ALKEM LABS LTD

Abbreviated New Drug Application (ANDA): 090836

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 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
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-Package Insert, Labeling-Container/Carton Labels

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 065253 AUROBINDO PHARMA LTD
CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Prescription No AB 062713 BELCHER PHARMS
CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Prescription No AB 065215 HIKMA
CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Prescription No AB 065229 LUPIN
CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Prescription No AB 065248 ORCHID HLTHCARE
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 065253 AUROBINDO PHARMA LTD
CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Prescription No AB 062713 BELCHER PHARMS
CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Prescription No AB 065215 HIKMA
CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Prescription No AB 065229 LUPIN
CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Prescription No AB 065248 ORCHID HLTHCARE
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
KEFLEX CEPHALEXIN EQ 750MG BASE CAPSULE;ORAL Prescription Yes AB 050405 PRAGMA
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