Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062058
Company: AM ANTIBIOTICS
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
08/03/1978 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
02/07/2011 SUPPL-8 Labeling

Label is not available on this site.

07/15/1997 SUPPL-1 Labeling

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 062058 AM ANTIBIOTICS
AMOXICILLIN AMOXICILLIN 250MG CAPSULE;ORAL Prescription No AB 065271 AUROBINDO
AMOXICILLIN AMOXICILLIN 250MG CAPSULE;ORAL Prescription No AB 062884 DAVA PHARMS INC
AMOXICILLIN AMOXICILLIN 250MG CAPSULE;ORAL Prescription No AB 065291 HIKMA PHARMS
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 DR REDDYS LABS INC

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 062058 AM ANTIBIOTICS
AMOXICILLIN AMOXICILLIN 500MG CAPSULE;ORAL Prescription No AB 065271 AUROBINDO
AMOXICILLIN AMOXICILLIN 500MG CAPSULE;ORAL Prescription No AB 062881 DAVA PHARMS INC
AMOXICILLIN AMOXICILLIN 500MG CAPSULE;ORAL Prescription No AB 065291 HIKMA PHARMS
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 DR REDDYS LABS INC

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