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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Covington
Dow
Chinese Patent Office
Farmers Insurance
QuintilesIMS
Chubb
Argus Health
Daiichi Sankyo
AstraZeneca

Generated: October 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205750

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NDA 205750 describes CHOLBAM, which is a drug marketed by Rtrx and is included in one NDA. It is available from one supplier. Additional details are available on the CHOLBAM profile page.

The generic ingredient in CHOLBAM is cholic acid. There are forty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cholic acid profile page.

Summary for NDA: 205750

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 205750

Ingredient-typeBile Acids and Salts

Suppliers and Packaging for NDA: 205750

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHOLBAM
cholic acid
CAPSULE;ORAL 205750 NDA Manchester Pharmaceuticals 45043-001 45043-001-02 90 CAPSULE in 1 BOTTLE (45043-001-02)
CHOLBAM
cholic acid
CAPSULE;ORAL 205750 NDA Manchester Pharmaceuticals 45043-002 45043-002-02 90 CAPSULE in 1 BOTTLE (45043-002-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Mar 17, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 17, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Mar 17, 2022
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Mar 17, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 17, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


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Serving leading biopharmaceutical companies globally:

AstraZeneca
Baxter
Teva
McKinsey
Johnson and Johnson
Moodys
Chinese Patent Office
QuintilesIMS
Medtronic
US Department of Justice

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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