Details for New Drug Application (NDA): 074823
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NDA 074823 describes TERAZOSIN HYDROCHLORIDE, which is a drug marketed by Ajanta Pharma Ltd, Bionpharma, Heritage Pharma Avet, Hikma, Jubilant Cadista, Pharmobedient, Ranbaxy Labs Ltd, Senores Pharms, Chartwell Rx, Ivax Sub Teva Pharms, Sandoz, and Teva, and is included in thirteen NDAs. It is available from eighteen 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. Nineteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the terazosin hydrochloride profile page.
Summary for 074823
| Tradename: | TERAZOSIN HYDROCHLORIDE |
| Applicant: | Senores Pharms |
| Ingredient: | terazosin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 074823
| Mechanism of Action | Adrenergic alpha-Antagonists |
Suppliers and Packaging for NDA: 074823
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TERAZOSIN HYDROCHLORIDE | terazosin hydrochloride | CAPSULE;ORAL | 074823 | ANDA | Amici Pharma, Inc. | 69292-201 | 69292-201-01 | 100 CAPSULE in 1 BOTTLE (69292-201-01) |
| TERAZOSIN HYDROCHLORIDE | terazosin hydrochloride | CAPSULE;ORAL | 074823 | ANDA | Amici Pharma, Inc. | 69292-201 | 69292-201-10 | 1000 CAPSULE in 1 BOTTLE (69292-201-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Mar 30, 1998 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | Mar 30, 1998 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Mar 30, 1998 | TE: | AB | RLD: | No | ||||
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