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. Thirty-nine 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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