Drug application
BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE (BISMUTH SUBSALICYLATE, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE)
Drugs@FDA ANDA 202584 · AILEX PHARMS LLC
Key facts
| Drug name | BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE |
|---|---|
| Active ingredients | BISMUTH SUBSALICYLATE, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 202584 |
| Company | AILEX PHARMS 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 |
| Marketing status | Prescription |
| Reference listed drug | No |
| Latest submission status date | Nov 30, 2018 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None 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: