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PYLERA (nda050786)- (140MG;125MG;125MG)

BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE LABS JUVISE
140MG;125MG;125MG
Yes Yes
2018-Dec-14 Expired
None None
None No
PYLERA is a combination of metronidazole, a nitroimidazole antimicrobial, tetracycline,-a tetracycline class antimicrobial and bismuth subcitrate potassium, indicated for use, in combination with omeprazole, for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.
2 0 2
Total Other Developers 6
Drugs with Suitability No
140MG;125MG;125MG ** ** Up - 2
NDA Sales Available Total Generic Sales Available
Yes 2
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
****** ****** **** ******* *************** **, *** *********** *** *** ***** ****, *********, *** ****** (**) *****, ****** ****** (***) ***

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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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