Details for New Drug Application (NDA): 218139
✉ Email this page to a colleague
NDA 218139 describes TEZRULY, which is a drug marketed by Novitium Pharma and is included in one NDA. There is one patent protecting this drug. Additional details are available on the TEZRULY profile page.
The generic ingredient in TEZRULY is terazosin hydrochloride. There are twenty-four drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the terazosin hydrochloride profile page.
The generic ingredient in TEZRULY is terazosin hydrochloride. There are twenty-four drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the terazosin hydrochloride profile page.
Summary for 218139
| Tradename: | TEZRULY |
| Applicant: | Novitium Pharma |
| Ingredient: | terazosin hydrochloride |
| Patents: | 1 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | EQ 1MG BASE/ML | ||||
| Approval Date: | Jul 29, 2024 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 18, 2042 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF HYPERTENSION IN PATIENTS WHO ARE IN NEED OF A LIQUID COMPOSITION OF TERAZOSIN | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 18, 2042 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) IN PATIENTS WHO ARE IN NEED OF A LIQUID COMPOSITION OF TERAZOSIN | ||||||||
Complete Access Available with Subscription
