Details for New Drug Application (NDA): 219482
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NDA 219482 describes TERAZOSIN HYDROCHLORIDE, which is a drug marketed by Ajanta Pharma Ltd, Apnar Pharma Lp, Bionpharma, Heritage Pharma Avet, Hikma, Jubilant Cadista, Pharmobedient, Ranbaxy Labs Ltd, Chartwell Rx, Ivax Sub Teva Pharms, Sandoz, and Teva, and is included in thirteen NDAs. It is available from nineteen suppliers. Additional details are available on the TERAZOSIN HYDROCHLORIDE profile page.
The generic ingredient in TERAZOSIN HYDROCHLORIDE 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 TERAZOSIN HYDROCHLORIDE 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 219482
| Tradename: | TERAZOSIN HYDROCHLORIDE |
| Applicant: | Ajanta Pharma Ltd |
| Ingredient: | terazosin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 219482
| Mechanism of Action | Adrenergic alpha-Antagonists |
Suppliers and Packaging for NDA: 219482
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TERAZOSIN HYDROCHLORIDE | terazosin hydrochloride | CAPSULE;ORAL | 219482 | ANDA | Ajanta Pharma USA Inc. | 27241-288 | 27241-288-01 | 100 CAPSULE in 1 BOTTLE (27241-288-01) |
| TERAZOSIN HYDROCHLORIDE | terazosin hydrochloride | CAPSULE;ORAL | 219482 | ANDA | Ajanta Pharma USA Inc. | 27241-288 | 27241-288-10 | 1000 CAPSULE in 1 BOTTLE (27241-288-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | May 12, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | May 12, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | May 12, 2025 | TE: | AB | RLD: | No | ||||
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