Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 064071
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PENICILLIN V POTASSIUM PENICILLIN V POTASSIUM EQ 250MG BASE TABLET;ORAL Prescription AB No No
PENICILLIN V POTASSIUM PENICILLIN V POTASSIUM EQ 500MG BASE TABLET;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
11/30/1995 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
10/28/2010 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

10/11/2012 SUPPL-6 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/064071s006lbl.pdf
09/30/2004 SUPPL-3 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/11/2012 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/064071s006lbl.pdf

PENICILLIN V POTASSIUM

TABLET;ORAL; EQ 250MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PENICILLIN V POTASSIUM PENICILLIN V POTASSIUM EQ 250MG BASE TABLET;ORAL Prescription No AB 065435 AUROBINDO PHARMA
PENICILLIN V POTASSIUM PENICILLIN V POTASSIUM EQ 250MG BASE TABLET;ORAL Prescription No AB 062936 DAVA PHARMS INC
PENICILLIN V POTASSIUM PENICILLIN V POTASSIUM EQ 250MG BASE TABLET;ORAL Prescription No AB 090549 HIKMA PHARMS
PENICILLIN V POTASSIUM PENICILLIN V POTASSIUM EQ 250MG BASE TABLET;ORAL Prescription No AB 064071 SANDOZ
PENICILLIN-VK PENICILLIN V POTASSIUM EQ 250MG BASE TABLET;ORAL Prescription No AB 060711 TEVA

TABLET;ORAL; EQ 500MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PENICILLIN V POTASSIUM PENICILLIN V POTASSIUM EQ 500MG BASE TABLET;ORAL Prescription No AB 065435 AUROBINDO PHARMA
PENICILLIN V POTASSIUM PENICILLIN V POTASSIUM EQ 500MG BASE TABLET;ORAL Prescription No AB 062935 DAVA PHARMS INC
PENICILLIN V POTASSIUM PENICILLIN V POTASSIUM EQ 500MG BASE TABLET;ORAL Prescription No AB 090549 HIKMA PHARMS
PENICILLIN V POTASSIUM PENICILLIN V POTASSIUM EQ 500MG BASE TABLET;ORAL Prescription No AB 064071 SANDOZ
PENICILLIN-VK PENICILLIN V POTASSIUM EQ 500MG BASE TABLET;ORAL Prescription No AB 060711 TEVA

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