| NDC Code | 58914-600-21 |
|---|
| Package Description | 1 BOTTLE in 1 BOX (58914-600-21) > 120 CAPSULE in 1 BOTTLE |
|---|
| Product NDC | 58914-600 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Pylera |
|---|
| Non-Proprietary Name | Bismuth Subcitrate Potassium, Metronidazole, Tetracycline Hydrochloride |
|---|
| Dosage Form | CAPSULE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20070501 |
|---|
| End Marketing Date | 20150228 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA050786 |
|---|
| Manufacturer | Aptalis Pharma US, Inc. |
|---|
| Substance Name | BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE |
|---|
| Strength | 140; 125; 125 |
|---|
| Strength Unit | mg/1; mg/1; mg/1 |
|---|
| Pharmacy Classes | Bismuth [Chemical/Ingredient],Bismuth [EPC],Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient],Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] |
|---|