Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 060711
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PENICILLIN-VK PENICILLIN V POTASSIUM EQ 250MG BASE TABLET;ORAL Prescription AB No No
PENICILLIN-VK PENICILLIN V POTASSIUM EQ 500MG BASE TABLET;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
07/03/1968 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
07/16/2014 SUPPL-39 Labeling-Package Insert

Label is not available on this site.

04/30/2008 SUPPL-38 Labeling

Label is not available on this site.

09/25/2007 SUPPL-37 Labeling

Label is not available on this site.

11/13/2001 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/2001 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/15/2001 SUPPL-26 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-25 Manufacturing (CMC)-Facility

Label is not available on this site.

08/28/1996 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/24/1996 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

09/21/1995 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/02/1994 SUPPL-21 Labeling

Label is not available on this site.

08/25/1993 SUPPL-20 Labeling

Label is not available on this site.

08/25/1993 SUPPL-19 Labeling

Label is not available on this site.

02/26/1993 SUPPL-18 Labeling

Label is not available on this site.

03/09/1993 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/09/1993 SUPPL-16 Labeling

Label is not available on this site.

11/10/1988 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

PENICILLIN-VK

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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