Details for New Drug Application (NDA): 213052
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The generic ingredient in PRAZOSIN HYDROCHLORIDE is prazosin hydrochloride. There are seventeen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the prazosin hydrochloride profile page.
Summary for 213052
Tradename: | PRAZOSIN HYDROCHLORIDE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | prazosin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213052
Mechanism of Action | Adrenergic alpha-Antagonists |
Medical Subject Heading (MeSH) Categories for 213052
Suppliers and Packaging for NDA: 213052
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PRAZOSIN HYDROCHLORIDE | prazosin hydrochloride | CAPSULE;ORAL | 213052 | ANDA | Aurobindo Pharma Limited | 59651-271 | 59651-271-01 | 100 CAPSULE in 1 BOTTLE (59651-271-01) |
PRAZOSIN HYDROCHLORIDE | prazosin hydrochloride | CAPSULE;ORAL | 213052 | ANDA | Aurobindo Pharma Limited | 59651-271 | 59651-271-99 | 1000 CAPSULE in 1 BOTTLE (59651-271-99) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 1MG BASE | ||||
Approval Date: | Mar 31, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 2MG BASE | ||||
Approval Date: | Mar 31, 2023 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Mar 31, 2023 | TE: | AB | RLD: | No |
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