Details for New Drug Application (NDA): 076051
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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 076051
Tradename: | LABETALOL HYDROCHLORIDE |
Applicant: | Baxter Hlthcare Corp |
Ingredient: | labetalol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 076051
Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 076051
Suppliers and Packaging for NDA: 076051
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LABETALOL HYDROCHLORIDE | labetalol hydrochloride | INJECTABLE;INJECTION | 076051 | ANDA | Baxter Healthcare Corporation | 36000-320 | 36000-320-10 | 10 VIAL in 1 CARTON (36000-320-10) / 4 mL in 1 VIAL (36000-320-01) |
LABETALOL HYDROCHLORIDE | labetalol hydrochloride | INJECTABLE;INJECTION | 076051 | ANDA | Baxter Healthcare Corporation | 36000-322 | 36000-322-02 | 1 VIAL in 1 CARTON (36000-322-02) / 20 mL in 1 VIAL (36000-322-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/ML | ||||
Approval Date: | Jul 5, 2002 | TE: | AP | RLD: | No |
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