Details for New Drug Application (NDA): 200908
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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 200908
Tradename: | LABETALOL HYDROCHLORIDE |
Applicant: | Endo Operations |
Ingredient: | labetalol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 200908
Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 200908
Suppliers and Packaging for NDA: 200908
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LABETALOL HYDROCHLORIDE | labetalol hydrochloride | TABLET;ORAL | 200908 | ANDA | Endo USA, Inc. | 49884-122 | 49884-122-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49884-122-01) |
LABETALOL HYDROCHLORIDE | labetalol hydrochloride | TABLET;ORAL | 200908 | ANDA | Endo USA, Inc. | 49884-122 | 49884-122-05 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49884-122-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Jul 10, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Jul 10, 2012 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Jul 10, 2012 | TE: | AB | RLD: | No |
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