Details for New Drug Application (NDA): 207863
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The generic ingredient in LABETALOL HYDROCHLORIDE is labetalol hydrochloride. There are fourteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.
Summary for 207863
Tradename: | LABETALOL HYDROCHLORIDE |
Applicant: | Hibrow Hlthcare |
Ingredient: | labetalol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 207863
Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 207863
Suppliers and Packaging for NDA: 207863
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LABETALOL HYDROCHLORIDE | labetalol hydrochloride | TABLET;ORAL | 207863 | ANDA | Bryant Ranch Prepack | 63629-2053 | 63629-2053-1 | 500 TABLET, FILM COATED in 1 BOTTLE (63629-2053-1) |
LABETALOL HYDROCHLORIDE | labetalol hydrochloride | TABLET;ORAL | 207863 | ANDA | Bryant Ranch Prepack | 63629-2054 | 63629-2054-1 | 100 TABLET, FILM COATED in 1 BOTTLE (63629-2054-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Feb 4, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Feb 4, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Feb 4, 2019 | TE: | AB | RLD: | No |
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