[e-drug] Sumamed registered in USA? (2)

["Malinowski, Henry J" <MALINOWSKI@cder.fda.gov>]

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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