Details for New Drug Application (NDA): 090699
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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 090699
Tradename: | LABETALOL HYDROCHLORIDE |
Applicant: | Gland Pharma Ltd |
Ingredient: | labetalol hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090699
Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 090699
Suppliers and Packaging for NDA: 090699
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LABETALOL HYDROCHLORIDE | labetalol hydrochloride | INJECTABLE;INJECTION | 090699 | ANDA | Alvogen Inc. | 47781-586 | 47781-586-29 | 1 VIAL, MULTI-DOSE in 1 CARTON (47781-586-29) / 20 mL in 1 VIAL, MULTI-DOSE |
LABETALOL HYDROCHLORIDE | labetalol hydrochloride | INJECTABLE;INJECTION | 090699 | ANDA | Alvogen Inc. | 47781-586 | 47781-586-56 | 1 VIAL, MULTI-DOSE in 1 CARTON (47781-586-56) / 40 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/ML | ||||
Approval Date: | Apr 3, 2012 | TE: | AP | RLD: | No |
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