Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 060456
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PENICILLIN-VK PENICILLIN V POTASSIUM EQ 125MG BASE/5ML FOR SOLUTION;ORAL Prescription AA No No
PENICILLIN-VK PENICILLIN V POTASSIUM EQ 250MG BASE/5ML FOR SOLUTION;ORAL Prescription AA 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
07/31/1968 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-52 Labeling-Package Insert

Label is not available on this site.

04/30/2008 SUPPL-48 Labeling

Label is not available on this site.

05/31/2007 SUPPL-46 Labeling

Label is not available on this site.

10/30/2001 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

07/27/2001 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/2001 SUPPL-40 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-39 Manufacturing (CMC)-Facility

Label is not available on this site.

08/19/1997 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

08/30/1996 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

03/27/1996 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

05/24/1996 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

07/14/1995 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

12/22/1994 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

02/02/1994 SUPPL-32 Labeling

Label is not available on this site.

08/25/1993 SUPPL-31 Labeling

Label is not available on this site.

02/26/1993 SUPPL-30 Labeling

Label is not available on this site.

11/10/1988 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

PENICILLIN-VK

FOR SOLUTION;ORAL; EQ 125MG BASE/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PENICILLIN V POTASSIUM PENICILLIN V POTASSIUM EQ 125MG BASE/5ML FOR SOLUTION;ORAL Prescription No AA 062981 DAVA PHARMS INC
PENICILLIN-VK PENICILLIN V POTASSIUM EQ 125MG BASE/5ML FOR SOLUTION;ORAL Prescription No AA 060456 TEVA

FOR SOLUTION;ORAL; EQ 250MG BASE/5ML
TE Code = AA

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/5ML FOR SOLUTION;ORAL Prescription No AA 062981 DAVA PHARMS INC
PENICILLIN-VK PENICILLIN V POTASSIUM EQ 250MG BASE/5ML FOR SOLUTION;ORAL Prescription No AA 060456 TEVA

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