E-DRUG: Sumamed registered in USA? (2)
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Please let us know if the Azithromycin Tablets 500mg sold
under brand Name Sumamed by Pliva dd is approved by CDER as
generic substitute of Zithrox of Pfizer.
You can check this link for drug products approved by FDA/CDER:
Approved Drug Products with Therapeutic Equivalence Evaluations
Orange Book
http://www.fda.gov/cder/orange/default.htm
Hank Malinowski Ph.D.
Mansfield Fellow
Director, Division of Pharmaceutical Evaluation II
Office of Clinical Pharmacology & Biopharmaceutics
Center for Drug Evaluation & Research
U.S. FDA
MALINOWSKI@cder.fda.gov
[I quickly checked, and although Pliva has many generics registered in USA,
azithromycin is not among them. WB]
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