Details for New Drug Application (NDA): 210971
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NDA 210971 describes PRAZOSIN HYDROCHLORIDE, which is a drug marketed by Alembic, Am Therap, Ani Pharms, Appco, Aurobindo Pharma Ltd, Dava Pharms Inc, Granules, Lannett Co Inc, Mankind Pharma, MSN, Mylan, Novitium Pharma, Purepac Pharm, Teva Pharms, and Watson Labs, and is included in twenty-three NDAs. It is available from twenty-eight suppliers. Additional details are available on the PRAZOSIN HYDROCHLORIDE profile page.
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.
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 210971
| Tradename: | PRAZOSIN HYDROCHLORIDE |
| Applicant: | Novitium Pharma |
| Ingredient: | prazosin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 210971
| Mechanism of Action | Adrenergic alpha-Antagonists |
Medical Subject Heading (MeSH) Categories for 210971
Suppliers and Packaging for NDA: 210971
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRAZOSIN HYDROCHLORIDE | prazosin hydrochloride | CAPSULE;ORAL | 210971 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8519 | 0615-8519-39 | 30 CAPSULE in 1 BLISTER PACK (0615-8519-39) |
| PRAZOSIN HYDROCHLORIDE | prazosin hydrochloride | CAPSULE;ORAL | 210971 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8520 | 0615-8520-39 | 30 CAPSULE in 1 BLISTER PACK (0615-8520-39) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Oct 3, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | Oct 3, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Oct 3, 2018 | TE: | AB | RLD: | No | ||||
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