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Generated: November 17, 2018

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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-four 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 205750
Tradename:CHOLBAM
Applicant:Rtrx
Ingredient:cholic acid
Patents:0
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 205750
Generic Entry Date for 205750*:
Constraining patent/regulatory exclusivity:
TREATMENT OF BILE ACID SYNTHESIS DISORDERS DUE TO SINGLE ENZYME DEFECTS
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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)

Profile 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:TREATMENT OF BILE ACID SYNTHESIS DISORDERS DUE TO SINGLE ENZYME DEFECTS

Profile 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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