Pylera - Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride
Navigation: NDC > Supplier starting with: A > APTALIS PHARMA US, INC.| Field | Value |
|---|---|
| NDC Code: | 58914-601 |
| Proprietary Name: | Pylera |
| Suffix: | |
| Non-Proprietary Name: | Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride |
| Dosage Form: | CAPSULE |
| Method: | ORAL |
| Original Marketing Date: | 01-08-2013 |
| Category Name: | NDA |
| Application Number: | NDA050786 |
| Labeler: | APTALIS PHARMA US, INC. |
| Substance Name: | BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE |
| Active Numerator Strength: | 140; 125; 125 |
| Active Ingredient Unit: | mg/1; mg/1; mg/1 |
| Pharm Classes: | Bismuth [Chemical/Ingredient],Bismuth [EPC],Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient],Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] |
| DEA Schedule: |