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Last Updated: October 5, 2024

Details for New Drug Application (NDA): 214522


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NDA 214522 describes TADLIQ, which is a drug marketed by Cmp Dev Llc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the TADLIQ profile page.

The generic ingredient in TADLIQ is tadalafil. There are twenty-five drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the tadalafil profile page.
Summary for 214522
Tradename:TADLIQ
Applicant:Cmp Dev Llc
Ingredient:tadalafil
Patents:3
Pharmacology for NDA: 214522
Mechanism of ActionPhosphodiesterase 5 Inhibitors
Medical Subject Heading (MeSH) Categories for 214522
Suppliers and Packaging for NDA: 214522
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TADLIQ tadalafil SUSPENSION;ORAL 214522 NDA CMP Pharma, Inc. 46287-045 46287-045-15 150 mL in 1 BOTTLE (46287-045-15)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength20MG/5ML
Approval Date:Jun 17, 2022TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Dec 24, 2038Product Flag?YSubstance Flag?Delist Request?
Patented Use:TADLIQ IS INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO IMPROVE EXERCISE ABILITY
Patent:⤷  Sign UpPatent Expiration:Dec 24, 2038Product Flag?YSubstance Flag?Delist Request?
Patented Use:TADLIQ IS INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO IMPROVE EXERCISE ABILITY
Patent:⤷  Sign UpPatent Expiration:Dec 24, 2038Product Flag?YSubstance Flag?Delist Request?
Patented Use:TADLIQ IS INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO IMPROVE EXERCISE ABILITY

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