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. Thirty 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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