All FDA drug approvals
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FDA drug approvals — brands starting with H
155 FDA applications with an approved original submission carry a brand starting with H, the earliest approved in 1939 and the most recent in 2026. FDA marks 82 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.
| Brand | Ingredient | Approved | Sponsor | Application |
|---|---|---|---|---|
| H.P. ACTHAR GEL | repository corticotropin | QUESTCOR PHARMA | NDA022432 | |
| HABITROL | nicotine | DR REDDYS LABS SA | NDA020076 | |
| HADLIMA | adalimumab-bwwd | SAMSUNG BIOEPIS CO LTD | BLA761059 | |
| HALAVEN | eribulin mesylate | EISAI INC | NDA201532 | |
| HALCION | triazolam | PFIZER | NDA017892 | |
| HALDOL | haloperidol | ORTHO MCNEIL | NDA015921 | |
| HALDOL | haloperidol lactate | ORTHO MCNEIL | NDA015922 | |
| HALDOL | haloperidol lactate | JANSSEN PHARMS | NDA015923 | |
| HALDOL | haloperidol decanoate | JANSSEN PHARMS | NDA018701 | |
| HALDRONE | paramethasone acetate | LILLY | NDA012772 | |
| HALFAN | halofantrine hydrochloride | GLAXOSMITHKLINE | NDA020250 | |
| HALFLYTELY | bisacodyl, polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride | BRAINTREE | NDA021551 | |
| HALOG | halcinonide | SUN PHARM INDS INC | NDA017556 | |
| HALOG | halcinonide | WESTWOOD SQUIBB | NDA017818 | |
| HALOG | halcinonide | SUN PHARM INDS INC | NDA017823 | |
| HALOG | halcinonide | SUN PHARM INDS INC | NDA017824 | |
| HALOG-E | halcinonide | SUN PHARM INDS INC | NDA018234 | |
| HALOTESTIN | fluoxymesterone | PHARMACIA AND UPJOHN | NDA010611 | |
| HALOTEX | haloprogin | WESTWOOD SQUIBB | NDA016942 | |
| HALOTEX | haloprogin | WESTWOOD SQUIBB | NDA016943 | |
| HARLIKU | nitisinone | CYCLE | NDA209449 | |
| HARMONYL | deserpidine | ABBVIE | NDA010796 | |
| HARVONI | ledipasvir, sofosbuvir | GILEAD SCIENCES INC | NDA205834 | |
| HARVONI | ledipasvir, sofosbuvir | GILEAD SCIENCES INC | NDA212477 | |
| HECTOROL | doxercalciferol | SANOFI | NDA020862 | |
| HECTOROL | doxercalciferol | SANOFI | NDA021027 | |
| HELICOSOL | urea c-13 | METABOLIC SOLUTIONS | NDA021092 | |
| HELIDAC | bismuth subsalicylate, metronidazole, tetracycline hydrochloride | CASPER PHARMA LLC | NDA050719 | |
| HELIUM, USP | helium | NORCO INC | NDA205819 | |
| HELIUM, USP | helium | AIRGAS USA LLC | NDA205843 | |
| HELIUM, USP | helium | PRAXAIR INC | NDA205851 | |
| HELIUM, USP | helium | PRAXAIR DISTRIBUTION MID-ATLANTIC LLC | NDA205911 | |
| HELIUM, USP | helium | PRAXAIR DISTRIBUTION INC | NDA205912 | |
| HELIUM, USP | helium | AIR LIQUIDE HEALTHCARE AMERICA CORP | NDA206026 | |
| HELIUM, USP | helium | LINDE GAS NORTH AMERICA LLC | NDA206826 | |
| HELIUM, USP | helium | NEXAIR LLC | NDA209033 | |
| HELIUM, USP | helium | A-OX WELDING SUPPLY CO, INC. | NDA211781 | |
| HELIUM, USP | helium | MATHESON TRI-GAS INC | NDA212539 | |
| HELIUM, USP | helium | ROBERTS OXYGEN CO INC | NDA213609 | |
| HELIUM, USP | helium | A G L WELDING SUPPLY CO INC | NDA213727 | |
| HELIUM, USP | helium | ILMO Products Company | NDA213990 | |
| HELIUM, USP | helium | WESTAIR GASES & EQUIPMENT INC | NDA214937 | |
| HELIUM, USP | helium | GENERAL AIR SERVICE & SUPPLY COMPANY | NDA216307 | |
| HEMABATE | carboprost tromethamine | PFIZER | NDA017989 | |
| HEMADY | dexamethasone | DEXCEL | NDA211379 | |
| HEMANGEOL | propranolol hydrochloride | ETON | NDA205410 | |
| HEMICLOR | chlorthalidone | PRM PHARMA | NDA218647 | |
| HEMLIBRA | emicizumab | GENENTECH INC | BLA761083 | |
| HEPARIN LOCK FLUSH | heparin sodium | HOSPIRA | NDA005264 | |
| HEPARIN SODIUM | heparin sodium | ASPEN GLOBAL INC | NDA000552 | |
| HEPARIN SODIUM | heparin sodium | PHARMACIA AND UPJOHN | NDA004570 | |
| HEPARIN SODIUM | heparin sodium | LILLY | NDA005521 | |
| HEPARIN SODIUM | heparin sodium | HIKMA | NDA017007 | |
| HEPARIN SODIUM | heparin sodium | HIKMA | NDA017037 | |
| HEPARIN SODIUM | heparin sodium | DR REDDYS | NDA017064 | |
| HEPARIN SODIUM | heparin sodium | EPIC PHARMA LLC | NDA017486 | |
| HEPARIN SODIUM | heparin sodium | FRESENIUS KABI USA | NDA017651 | |
| HEPARIN SODIUM | heparin sodium | PHARM SPEC | NDA017780 | |
| HEPARIN SODIUM | heparin sodium | ABRAXIS PHARM | NDA017979 | |
| HEPARIN SODIUM | heparin sodium | PFIZER | NDA201370 | |
| HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | heparin sodium | HOSPIRA | NDA019339 | |
| HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9% | heparin sodium | HOSPIRA | NDA018911 | |
| HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | heparin sodium | BAXTER HLTHCARE | NDA018609 | |
| HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER | heparin sodium | BAXTER HLTHCARE | NDA018814 | |
| HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | heparin sodium | B BRAUN | NDA019134 | |
| HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | heparin sodium | HOSPIRA | NDA019805 | |
| HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | heparin sodium | B BRAUN | NDA019952 | |
| HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% | heparin sodium | FRESENIUS KABI USA | NDA017029 | |
| HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | heparin sodium | B BRAUN | NDA019953 | |
| HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | heparin sodium | HOSPIRA | NDA018916 | |
| HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | heparin sodium | B BRAUN | NDA019135 | |
| HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | heparin sodium | B BRAUN | NDA019802 | |
| HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | heparin sodium | B BRAUN | NDA019042 | |
| HEPATAMINE 8% | amino acids | B BRAUN | NDA018676 | |
| HEPATOLITE | technetium tc-99m disofenin kit | SUN PHARM INDS INC | NDA018467 | |
| HEPCLUDEX | bulevirtide-gmod | GILEAD SCIENCES INC | BLA761468 | |
| HEPSERA | adefovir dipivoxil | GILEAD | NDA021449 | |
| HEPZATO | melphalan hydrochloride | DELCATH SYSTEMS INC | NDA201848 | |
| HERCEPTIN | trastuzumab | GENENTECH | BLA103792 | |
| HERCEPTIN HYLECTA | trastuzumab and hyaluronidase-oysk | GENENTECH INC | BLA761106 | |
| HERCESSI | trastuzumab-strf | ACCORD BIOPHARMA INC. | BLA761346 | |
| HERNEXEOS | zongertinib | BOEHRINGER INGELHEIM | NDA219042 | |
| HERPLEX | idoxuridine | ALLERGAN | NDA013935 | |
| HERZUMA | trastuzumab-pkrb | CELLTRION INC | BLA761091 | |
| HETLIOZ | tasimelteon | VANDA PHARMS INC | NDA205677 | |
| HETLIOZ LQ | tasimelteon | VANDA PHARMS INC | NDA214517 | |
| HETRAZAN | diethylcarbamazine citrate | LEDERLE | NDA006459 | |
| HEXA-GERM | hexachlorophene | HUNTINGTON LABS | NDA017411 | |
| HEXABRIX | ioxaglate meglumine, ioxaglate sodium | GUERBET | NDA018905 | |
| HEXADROL | dexamethasone | ASPEN GLOBAL INC | NDA012674 | |
| HEXADROL | dexamethasone | ASPEN GLOBAL INC | NDA012675 | |
| HEXADROL | dexamethasone sodium phosphate | ASPEN GLOBAL INC | NDA014694 | |
| HEXALEN | altretamine | EISAI INC | NDA019926 | |
| HIBICLENS | chlorhexidine gluconate | MOLNLYCKE HLTH | NDA017768 | |
| HIBICLENS | chlorhexidine gluconate | MOLNLYCKE HLTH | NDA018423 | |
| HIBISTAT | chlorhexidine gluconate | MOLNLYCKE HLTH | NDA018300 | |
| HICON | sodium iodide i-131 | JUBILANT | NDA021305 | |
| HIPPURAN I 131 | iodohippurate sodium i-131 | MALLINCKRODT | NDA016666 | |
| HIPPUTOPE | iodohippurate sodium i-131 | BRACCO | NDA015419 | |
| HIPREX | methenamine hippurate | ESJAY PHARMA | NDA017681 | |
| HISTAMINE PHOSPHATE | histamine phosphate | LILLY | NDA000734 | |
| HIVID | zalcitabine | ROCHE | NDA020199 | |
| HIWOLFIA | rauwolfia serpentina root | BOWMAN PHARMS | NDA009276 | |
| HMS | medrysone | ALLERGAN | NDA016624 | |
| HORIZANT | gabapentin enacarbil | AZURITY | NDA022399 | |
| HULIO | adalimumab-fkjp | MYLAN PHARMS INC | BLA761154 | |
| HUMALOG KWIKPEN | insulin lispro recombinant | LILLY | BLA020563 | |
| HUMALOG KWIKPEN | insulin lispro recombinant | ELI LILLY AND CO | BLA205747 | |
| HUMALOG MIX 50/50 KWIKPEN | insulin lispro protamine recombinant, insulin lispro recombinant | LILLY | BLA021018 | |
| HUMALOG MIX 75/25 PEN | insulin lispro protamine recombinant, insulin lispro recombinant | LILLY | BLA021017 | |
| HUMATROPE | somatropin | LILLY | BLA019640 | |
| HUMEGON | menotropins (fsh, lh) | ORGANON USA INC | BLA020328 | |
| HUMIRA | adalimumab | ABBVIE INC | BLA125057 | |
| HUMORSOL | demecarium bromide | MERCK | NDA011860 | |
| HUMULIN 70/30 PEN | insulin recombinant human, insulin susp isophane recombinant human | LILLY | BLA019717 | |
| HUMULIN N | insulin susp isophane recombinant human | LILLY | BLA018781 | |
| HUMULIN R PEN | insulin recombinant human, insulin human | LILLY | BLA018780 | |
| HYCAMTIN | topotecan hydrochloride | SANDOZ | NDA020671 | |
| HYCAMTIN | topotecan hydrochloride | SANDOZ | NDA020981 | |
| HYCODAN | homatropine methylbromide, hydrocodone bitartrate | GENUS | NDA005213 | |
| HYCOFENIX | guaifenesin, hydrocodone bitartrate, pseudoephedrine hydrochloride | CHARTWELL RX | NDA022279 | |
| HYDASE | hyaluronidase | AKORN INC | BLA021716 | |
| HYDELTRA-TBA | prednisolone tebutate | MERCK | NDA010562 | |
| HYDERGINE | ergoloid mesylates | NOVARTIS | NDA009087 | |
| HYDERGINE | ergoloid mesylates | NOVARTIS | NDA017993 | |
| HYDERGINE | ergoloid mesylates | NOVARTIS | NDA018418 | |
| HYDERGINE LC | ergoloid mesylates | NOVARTIS | NDA018706 | |
| HYDROCORTISONE | hydrocortisone | PANRAY | NDA009659 | |
| HYDROCORTISONE ACETATE | hydrocortisone acetate | EPIC PHARMA LLC | NDA009637 | |
| HYDROCORTONE | hydrocortisone acetate | MERCK | NDA008228 | |
| HYDROCORTONE | hydrocortisone | MERCK | NDA008506 | |
| HYDROCORTONE | hydrocortisone sodium phosphate | MERCK | NDA012052 | |
| HYDRODIURIL | hydrochlorothiazide | MERCK | NDA011835 | |
| HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | HOSPIRA INC | NDA200403 | |
| HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | HIKMA | NDA217812 | |
| HYDROMOX | quinethazone | LEDERLE | NDA013264 | |
| HYDROPRES 25 | hydrochlorothiazide, reserpine | MERCK | NDA011958 | |
| HYDROXYPROGESTERONE CAPROATE | hydroxyprogesterone caproate | ALLERGAN | NDA017439 | |
| HYDROXYSTILBAMIDINE ISETHIONATE | hydroxystilbamidine isethionate | SANOFI AVENTIS US | NDA009166 | |
| HYFTOR | sirolimus | NOBELPHARMA | NDA213478 | |
| HYGROTON | chlorthalidone | SANOFI AVENTIS US | NDA012283 | |
| HYLENEX RECOMBINANT | hyaluronidase recombinant human | HALOZYME THERAP | BLA021859 | |
| HYLOREL | guanadrel sulfate | PHARMACIA AND UPJOHN | NDA018104 | |
| HYMPAVZI | marstacimab-hncq | PFIZER INC | BLA761369 | |
| HYPAQUE | diatrizoate sodium | GE HEALTHCARE | NDA011386 | |
| HYPAQUE | diatrizoate meglumine | GE HEALTHCARE | NDA016403 | |
| HYPAQUE SODIUM 20% | diatrizoate sodium | GE HEALTHCARE | NDA009561 | |
| HYPAQUE-M,90% | diatrizoate meglumine, diatrizoate sodium | GE HEALTHCARE | NDA010220 | |
| HYPERSTAT | diazoxide | SCHERING | NDA016996 | |
| HYPROTIGEN 5% | protein hydrolysate | B BRAUN | NDA006170 | |
| HYRIMOZ | adalimumab-adaz | SANDOZ INC | BLA761071 | |
| HYRNUO | sevabertinib | BAYER HEALTHCARE | NDA219972 | |
| HYTRIN | terazosin hydrochloride | ABBOTT | NDA019057 | |
| HYTRIN | terazosin hydrochloride | ABBOTT | NDA020347 | |
| HYZAAR | hydrochlorothiazide, losartan potassium | ORGANON | NDA020387 |