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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 56-Antibiotics (Human/Animal)

Entry/doc/line/sfx Refusal Date Product
E7E-1026048-2/4/2 06-Apr-2012 56ACA20 3005793212 Sandoz Inc United States
M21-0745355-9/1/1 06-Apr-2012 56BAA05 3006094247 Research Pharmaceutical Co Ltd China
112-2901731-9/3/1 26-Apr-2012 56BCH03 3003972791 Glaxo Wellcome Production France
112-2901731-9/2/1 26-Apr-2012 56BCH03 3001229385 Corden Pharma Latina S.p.A. Italy
EKL-1001049-2/1/1 10-Apr-2012 56BXS03 3006531950 Zhuhai United Laboratories Co. Ltd. China
112-6952192-3/1/1 27-Apr-2012 56CCA64 3005531363 Sanofi Synthelabo Otc France
112-2901731-9/5/1 26-Apr-2012 56CCH99 3007684569 lCadila Pharmaceuticals Limited India
112-2901731-9/1/2 26-Apr-2012 56CCH99 3008757171 Meditec Tunisia
UPS-5660906-4/1/1 05-Apr-2012 56EAH22 3009436119 Jose De Jesus Zuluaga Colombia
336-6363951-0/1/1 26-Apr-2012 56HIS24 3004265295 Zhejiang Medicines & Health Products Import & Export Co. Ltd China
XXX-0177611-8/1/3 09-Apr-2012 56I76 3007611307 Cipla India
XXX-0177592-0/1/3 09-Apr-2012 56I76 3009102764 Unison Pharmaceuticals India
112-2950157-7/1/5 26-Apr-2012 56ICB76 3007501748 Alembic Ltd India
E7E-1026048-2/4/5 06-Apr-2012 56IDA10 3003064821 Abbott Laboratories United States
UPS-5856092-7/1/1 12-Apr-2012 56JCY20 3003516629 Pfizer Laboratoriesfse Comptabilite Fourniss France
XXX-0177592-0/1/6 09-Apr-2012 56K99 3009449639 Terrace pharmaceutical Singapore
XXX-0177592-0/1/4 09-Apr-2012 56K99 3004993131 mankind pharma pvt ltd India
XXX-0177592-0/1/2 09-Apr-2012 56K99 3009449639 Terrace pharmaceutical Singapore
112-6666343-9/1/2 10-Apr-2012 56KCO10 3000245736 Novartis Biociencias S.A. Brazil
112-6593828-7/1/1 24-Apr-2012 56OKT03 3008513396 Zhejiang Menovo Pharmaceutical Co. Ltd China
112-7076681-4/1/1 27-Apr-2012 56YCY99 3004152717 Glaxosmithkline Brasil Ltda Brazil
523-0964500-1/1/1 05-Apr-2012 56YJR99 3006409304 Ancheng Pharma Limited China