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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065291
Company: HIKMA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXICILLIN AMOXICILLIN 250MG CAPSULE;ORAL Prescription AB No No
AMOXICILLIN AMOXICILLIN 500MG 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
02/05/2007 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
11/25/2014 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

AMOXICILLIN

CAPSULE;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMOXICILLIN AMOXICILLIN 250MG CAPSULE;ORAL Prescription No AB 065271 AUROBINDO
AMOXICILLIN AMOXICILLIN 250MG CAPSULE;ORAL Prescription No AB 062058 CHARTWELL
AMOXICILLIN AMOXICILLIN 250MG CAPSULE;ORAL Prescription No AB 065291 HIKMA PHARMS
AMOXICILLIN AMOXICILLIN 250MG CAPSULE;ORAL Prescription No AB 207471 MICRO LABS
AMOXICILLIN AMOXICILLIN 250MG CAPSULE;ORAL Prescription No AB 064076 SANDOZ
AMOXICILLIN AMOXICILLIN 250MG CAPSULE;ORAL Prescription No AB 061926 TEVA
AMOXIL AMOXICILLIN 250MG CAPSULE;ORAL Prescription No AB 062216 US ANTIBIOTICS

CAPSULE;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMOXICILLIN AMOXICILLIN 500MG CAPSULE;ORAL Prescription No AB 065271 AUROBINDO
AMOXICILLIN AMOXICILLIN 500MG CAPSULE;ORAL Prescription No AB 062058 CHARTWELL
AMOXICILLIN AMOXICILLIN 500MG CAPSULE;ORAL Prescription No AB 065291 HIKMA PHARMS
AMOXICILLIN AMOXICILLIN 500MG CAPSULE;ORAL Prescription No AB 207471 MICRO LABS
AMOXICILLIN AMOXICILLIN 500MG CAPSULE;ORAL Prescription No AB 064076 SANDOZ
AMOXICILLIN AMOXICILLIN 500MG CAPSULE;ORAL Prescription No AB 061926 TEVA
AMOXIL AMOXICILLIN 500MG CAPSULE;ORAL Prescription No AB 062216 US ANTIBIOTICS
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