Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065248
Company: ORCHID HLTHCARE
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/28/2005 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
09/29/2011 SUPPL-8 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

03/08/2006 SUPPL-3 Labeling

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
CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Prescription No AB 065152 YUNG SHIN PHARM
KEFLEX CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Prescription Yes AB 050405 PRAGMA

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
CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Prescription No AB 065152 YUNG SHIN PHARM
KEFLEX CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Prescription Yes AB 050405 PRAGMA

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