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Details for New Drug Application (NDA): 018716
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NDA 018716 describes TRANDATE, which is a drug marketed by Sebela Ireland Ltd, Cnty Line Pharms, and Glaxosmithkline, and is included in three NDAs. It is available from four suppliers. Additional details are available on the TRANDATE profile page.
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.
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 |
| 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 | 43199-037-01 | 100 TABLET in 1 BOTTLE (43199-037-01) |
| TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716 | NDA | County Line Pharmaceuticals LLC | 43199-037 | 43199-037-05 | 500 TABLET in 1 BOTTLE (43199-037-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | May 24, 1985 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Aug 1, 1984 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Aug 1, 1984 | TE: | AB | RLD: | Yes | ||||
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 | 018716-003 | Aug 1, 1984 | Start Trial | Start Trial |
| Cnty Line Pharms | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-003 | Aug 1, 1984 | Start Trial | Start Trial |
| Cnty Line Pharms | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-001 | May 24, 1985 | Start Trial | Start Trial |
| Cnty Line Pharms | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-004 | Aug 1, 1984 | Start Trial | Start Trial |
| Cnty Line Pharms | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-002 | Aug 1, 1984 | Start Trial | Start Trial |
| Cnty Line Pharms | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-002 | Aug 1, 1984 | Start Trial | Start Trial |
| Cnty Line Pharms | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-004 | Aug 1, 1984 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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