Details for New Drug Application (NDA): 021287
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The generic ingredient in UROXATRAL is alfuzosin hydrochloride. There are nineteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the alfuzosin hydrochloride profile page.
Summary for 021287
Tradename: | UROXATRAL |
Applicant: | Concordia |
Ingredient: | alfuzosin hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 021287
Mechanism of Action | Adrenergic alpha-Antagonists |
Suppliers and Packaging for NDA: 021287
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
UROXATRAL | alfuzosin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021287 | NDA | Concordia Pharmaceuticals Inc. | 59212-200 | 59212-200-10 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-10) |
UROXATRAL | alfuzosin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021287 | NDA | Concordia Pharmaceuticals Inc. | 59212-200 | 59212-200-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
Approval Date: | Jun 12, 2003 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021287
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Concordia | UROXATRAL | alfuzosin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021287-001 | Jun 12, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Concordia | UROXATRAL | alfuzosin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021287-001 | Jun 12, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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