Details for New Drug Application (NDA): 050786
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The generic ingredient in PYLERA is bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride. There are twenty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride profile page.
Summary for 050786
Tradename: | PYLERA |
Applicant: | Labs Juvise |
Ingredient: | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 050786
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 050786 | NDA | H2-Pharma, LLC | 61269-380 | 61269-380-12 | 10 BLISTER PACK in 1 BOX (61269-380-12) / 12 CAPSULE in 1 BLISTER PACK |
PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 050786 | NDA | H2-Pharma, LLC | 61269-385 | 61269-385-12 | 1 BLISTER PACK in 1 BOX (61269-385-12) / 120 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 140MG;125MG;125MG | ||||
Approval Date: | Sep 28, 2006 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 050786
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Labs Juvise | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 050786-001 | Sep 28, 2006 | ⤷ Subscribe | ⤷ Subscribe |
Labs Juvise | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 050786-001 | Sep 28, 2006 | ⤷ Subscribe | ⤷ Subscribe |
Labs Juvise | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 050786-001 | Sep 28, 2006 | ⤷ Subscribe | ⤷ Subscribe |
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