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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050719

HELIDAC (BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE)
262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
Proprietary Name: HELIDAC
Dosage Form; Route of Administration: TABLET, CHEWABLE, TABLET, CAPSULE; ORAL
Strength: 262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050719
Product Number: 001
Approval Date: Aug 15, 1996
Applicant Holder Full Name: CASPER PHARMA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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