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-seven suppliers are listed for this compound. Additional details are available on the tadalafil profile page.
The generic ingredient in TADLIQ is tadalafil. There are twenty-five drug master file entries for this compound. Forty-seven 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 Action | Phosphodiesterase 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: | RX | Dosage: | SUSPENSION;ORAL | Strength | 20MG/5ML | ||||
| Approval Date: | Jun 17, 2022 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 24, 2038 | Product Flag? | Y | Substance 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 Up | Patent Expiration: | Dec 24, 2038 | Product Flag? | Y | Substance 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 Up | Patent Expiration: | Dec 24, 2038 | Product Flag? | Y | Substance 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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