FDA Drug Application (050719) for HELIDAC by SEBELA IRELAND LTD

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Application Number050719
Product Number001
FormTABLET, CHEWABLE, TABLET, CAPSULE;ORAL
Dosage262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Product Market Status Discontinued
Therapeutic Equivalence Evaluation Code
Reference Drug
Drug NameHELIDAC
Active IngredientBISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE



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