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Details for New Drug Application (NDA): 050786

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NDA 050786 describes PYLERA, which is a drug marketed by Forest Labs Llc and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the PYLERA profile page.

The generic ingredient in PYLERA is bismuth subcitrate potassium; metronidazole; tetracycline. There are twenty-one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bismuth subcitrate potassium; metronidazole; tetracycline profile page.

Summary for NDA: 050786

Tradename:
PYLERA
Applicant:
Forest Labs Llc
Ingredient:
bismuth subcitrate potassium; metronidazole; tetracycline
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 050786

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
CAPSULE;ORAL 050786 NDA Physicians Total Care, Inc. 54868-6151 54868-6151-0 1 BOTTLE in 1 BOX (54868-6151-0) > 120 CAPSULE in 1 BOTTLE
PYLERA
bismuth subcitrate potassium; metronidazole; tetracycline
CAPSULE;ORAL 050786 NDA Aptalis Pharma US, Inc. 58914-601 58914-601-20 1 BLISTER PACK in 1 BOX (58914-601-20) > 120 CAPSULE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength140MG;125MG;125MG
Approval Date:Sep 28, 2006TE:RLD:Yes
Patent:6,350,468Patent Expiration:Dec 14, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:PYLERA CAPSULES, IN COMBINATION WITH OMEPRAZOLE ARE INDICATED FOR THE TREATMENT OF PATIENTS WITH HELICOBACTER PYLORI INFECTION AND DUODENAL ULCER DISEASE TO ERADICATE H. PYLORI
Patent:6,350,468Patent Expiration:Dec 14, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PATIENTS WITH H. PYLORI INFECTION AND DUODENAL ULCER DISEASE

Expired Orange Book Patents for NDA: 050786

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs Llc
PYLERA
bismuth subcitrate potassium; metronidazole; tetracycline
CAPSULE;ORAL050786-001Sep 28, 20065,196,205► subscribe
Forest Labs Llc
PYLERA
bismuth subcitrate potassium; metronidazole; tetracycline
CAPSULE;ORAL050786-001Sep 28, 20065,476,669► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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