Details for New Drug Application (NDA): 050719
✉ Email this page to a colleague
NDA 050719 describes HELIDAC, which is a drug marketed by Casper Pharma Llc and is included in one NDA. Additional details are available on the HELIDAC profile page.
The generic ingredient in HELIDAC is bismuth subsalicylate; metronidazole; tetracycline hydrochloride. There are twenty-two drug master file entries for this compound. Additional details are available on the bismuth subsalicylate; metronidazole; tetracycline hydrochloride profile page.
The generic ingredient in HELIDAC is bismuth subsalicylate; metronidazole; tetracycline hydrochloride. There are twenty-two drug master file entries for this compound. Additional details are available on the bismuth subsalicylate; metronidazole; tetracycline hydrochloride profile page.
Summary for 050719
| Tradename: | HELIDAC |
| Applicant: | Casper Pharma Llc |
| Ingredient: | bismuth subsalicylate; metronidazole; tetracycline hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | 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| 262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Aug 15, 1996 | TE: | RLD: | Yes | |||||
Complete Access Available with Subscription
