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Details for New Drug Application (NDA): 018716
The generic ingredient in TRANDATE is hydrochlorothiazide; labetalol hydrochloride. There are thirty-two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; labetalol hydrochloride profile page.
Summary for 018716
Tradename: | TRANDATE |
Applicant: | Cnty Line Pharms |
Ingredient: | labetalol hydrochloride |
Patents: | 0 |
Therapeutic Class: | Cardiovascular Agents |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 018716
Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 018716
Suppliers and Packaging for NDA: 018716
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716 | NDA | County Line Pharmaceuticals LLC | 43199-037 | N | 43199-037-05 |
TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716 | NDA | County Line Pharmaceuticals LLC | 43199-037 | N | 43199-037-01 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | May 24, 1985 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Aug 1, 1984 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Aug 1, 1984 | TE: | AB | RLD: | No |
Expired US Patents for NDA 018716
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cnty Line Pharms | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-004 | Aug 1, 1984 | ➤ Sign Up | ➤ Sign Up |
Cnty Line Pharms | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-002 | Aug 1, 1984 | ➤ Sign Up | ➤ Sign Up |
Cnty Line Pharms | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-002 | Aug 1, 1984 | ➤ Sign Up | ➤ Sign Up |
Cnty Line Pharms | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-001 | May 24, 1985 | ➤ Sign Up | ➤ Sign Up |
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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