Details for New Drug Application (NDA): 218139
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NDA 218139 describes TEZRULY, which is a drug marketed by Novitium Pharma and is included in one NDA. It is available from one supplier. There are two patents 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 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 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: | 2 |
Pharmacology for NDA: 218139
| Mechanism of Action | Adrenergic alpha-Antagonists |
Suppliers and Packaging for NDA: 218139
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TEZRULY | terazosin hydrochloride | SOLUTION;ORAL | 218139 | NDA | ANI Pharmaceuticals, Inc. | 70954-592 | 70954-592-10 | 150 mL in 1 BOTTLE (70954-592-10) |
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: | 11,224,572 | Patent Expiration: | Feb 1, 2041 | 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: | 11,224,572 | Patent Expiration: | Feb 1, 2041 | 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 | ||||||||
| Patent: | 12,427,108 | Patent Expiration: | Feb 1, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF HYPERTENSION IN PATIENTS WHO ARE IN NEED OF A LIQUID COMPOSITION OF TERAZOSIN | ||||||||
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