Pylera - Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride
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Field |
Value |
NDC Code: |
58914-600 |
Proprietary Name: |
Pylera |
Suffix: |
|
Non-Proprietary Name: |
Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride |
Dosage Form: |
CAPSULE |
Method: |
ORAL |
Original Marketing Date: |
01-05-2007 |
End of Marketing: |
28-02-2015 |
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: |
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