Details for New Drug Application (NDA): 075317
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NDA 075317 describes TERAZOSIN HYDROCHLORIDE, which is a drug marketed by Apnar Pharma Lp, Bionpharma, Heritage Pharma Avet, Hikma, Jubilant Cadista, Norvium Bioscience, Ranbaxy Labs Ltd, Chartwell Rx, Ivax Sub Teva Pharms, Sandoz, and Teva, and is included in twelve NDAs. It is available from twenty-one 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-one 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-one suppliers are listed for this compound. Additional details are available on the terazosin hydrochloride profile page.
Summary for 075317
| Tradename: | TERAZOSIN HYDROCHLORIDE |
| Applicant: | Jubilant Cadista |
| Ingredient: | terazosin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 075317
| Mechanism of Action | Adrenergic alpha-Antagonists |
Suppliers and Packaging for NDA: 075317
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TERAZOSIN HYDROCHLORIDE | terazosin hydrochloride | CAPSULE;ORAL | 075317 | ANDA | AvKARE | 42291-820 | 42291-820-10 | 1000 CAPSULE in 1 BOTTLE (42291-820-10) |
| TERAZOSIN HYDROCHLORIDE | terazosin hydrochloride | CAPSULE;ORAL | 075317 | ANDA | AvKARE | 42291-821 | 42291-821-10 | 1000 CAPSULE in 1 BOTTLE (42291-821-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Dec 20, 2004 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | Dec 20, 2004 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Dec 20, 2004 | TE: | AB | RLD: | No | ||||
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