| 61269-381-12 |
61269-381 |
HUMAN PRESCRIPTION DRUG |
PYLERA |
BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE |
CAPSULE |
ORAL |
20250818 |
N/A |
NDA |
NDA050786 |
H2-Pharma, LLC |
BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE |
140 mg/1; 125 mg/1; 125 mg/1 |
10 BLISTER PACK in 1 BOX (61269-381-12) / 12 CAPSULE in 1 BLISTER PACK |
| 61269-386-12 |
61269-386 |
HUMAN PRESCRIPTION DRUG |
Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride |
Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride |
CAPSULE |
ORAL |
20250701 |
N/A |
NDA AUTHORIZED GENERIC |
NDA050786 |
H2-Pharma, LLC |
BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE |
140 mg/1; 125 mg/1; 125 mg/1 |
10 BLISTER PACK in 1 BOX (61269-386-12) / 12 CAPSULE in 1 BLISTER PACK |
| 61269-380-12 |
61269-380 |
HUMAN PRESCRIPTION DRUG |
PYLERA |
BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, and TETRACYCLINE HYDROCHLORIDE |
CAPSULE |
ORAL |
20231001 |
N/A |
NDA |
NDA050786 |
H2-Pharma, LLC |
BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE |
140 mg/1; 125 mg/1; 125 mg/1 |
10 BLISTER PACK in 1 BOX (61269-380-12) / 12 CAPSULE in 1 BLISTER PACK |