Details for New Drug Application (NDA): 209603
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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 209603
Tradename: | LABETALOL HYDROCHLORIDE |
Applicant: | Appco |
Ingredient: | labetalol hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209603
Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 209603
Suppliers and Packaging for NDA: 209603
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LABETALOL HYDROCHLORIDE | labetalol hydrochloride | TABLET;ORAL | 209603 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8512 | 0615-8512-39 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8512-39) |
LABETALOL HYDROCHLORIDE | labetalol hydrochloride | TABLET;ORAL | 209603 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8513 | 0615-8513-39 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8513-39) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Jun 20, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Jun 20, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Jun 20, 2018 | TE: | AB | RLD: | No |
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