Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065448
Company: ISTITUTO BIO ITA SPA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE;INJECTION Prescription AP No No
PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE;INJECTION Prescription AP 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
08/18/2009 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
01/30/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

08/24/2012 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

PENICILLIN G POTASSIUM

INJECTABLE;INJECTION; 5,000,000 UNITS/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 205043 ACS DOBFAR SPA
PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 065149 HANFORD GC
PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 065448 ISTITUTO BIO ITA SPA
PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 065079 SANDOZ
PFIZERPEN PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 060657 PFIZER

INJECTABLE;INJECTION; 20,000,000 UNITS/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 205043 ACS DOBFAR SPA
PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 065149 HANFORD GC
PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 065448 ISTITUTO BIO ITA SPA
PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 065079 SANDOZ
PFIZERPEN PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 060657 PFIZER

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