Application Nr Approved Date Route Status External Links
ANDA075215 1999-07-29 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

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

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
2. Carnauba Wax CARNAUBA WAX Unresolved MISC-Miscellaneous 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. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
6. 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.
7. Ferric Oxide Yellow FERRIC OXIDE YELLOW Unresolved

Active Ingredients ( 1 Total)

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

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