Application Nr Approved Date Route Status External Links
ANDA075133 1998-08-03 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Labetalol Hydrochloride Tablets, Usp Are Indicated In The Management Of Hypertension. Labetalol Hydrochloride Tablets, Usp May Be Used Alone Or In Combination With Other Antihypertensive Agents, Especially Thiazide And Loop Diuretics.

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Hypromelloses HYPROMELLOSES Unresolved
4. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
8. Water WATER Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Labetalol Hydrochloride LABETALOL HYDROCHLORIDE ZINC416

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