Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062981
Company: DAVA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PENICILLIN V POTASSIUM PENICILLIN V POTASSIUM EQ 125MG BASE/5ML FOR SOLUTION;ORAL Prescription AA No No
PENICILLIN V POTASSIUM PENICILLIN V POTASSIUM EQ 250MG BASE/5ML FOR SOLUTION;ORAL Prescription AA 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
02/10/1989 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
12/15/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/06/1993 SUPPL-3 Labeling

Label is not available on this site.

12/06/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/06/1994 SUPPL-1 Labeling

Label is not available on this site.

PENICILLIN V POTASSIUM

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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