Drug application
HELIDAC (BISMUTH SUBSALICYLATE, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE)
Drugs@FDA NDA 050719 · CASPER PHARMA LLC
Key facts
| Drug name | HELIDAC |
|---|---|
| Active ingredients | BISMUTH SUBSALICYLATE, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE |
| Application type | NDA |
| Application number | 050719 |
| Company | CASPER PHARMA LLC |
| Dosage forms | 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| 262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness… |
| Marketing status | Discontinued |
| Reference listed drug | Yes |
| Latest submission class | Type 4 - New Combination |
| Latest submission status date | Aug 15, 1996 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 10–99 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- No FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: