All FDA drug approvals
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FDA drug approvals — brands starting with X
91 FDA applications with an approved original submission carry a brand starting with X, the earliest approved in 1948 and the most recent in 2026. FDA marks 30 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.
| Brand | Ingredient | Approved | Sponsor | Application |
|---|---|---|---|---|
| XACDURO (COPACKAGED) | durlobactam sodium, sulbactam sodium | ENTASIS THERAP | NDA216974 | |
| XACIATO | clindamycin phosphate | ORGANON LLC | NDA215650 | |
| XADAGO | safinamide mesylate | MDD US | NDA207145 | |
| XALATAN | latanoprost | UPJOHN | NDA020597 | |
| XALKORI | crizotinib | PF PRISM CV | NDA202570 | |
| XALKORI | crizotinib | PF PRISM CV | NDA217581 | |
| XANAX | alprazolam | UPJOHN | NDA018276 | |
| XANAX XR | alprazolam | UPJOHN | NDA021434 | |
| XARACOLL | bupivacaine hydrochloride | INNOCOLL PHARMS | NDA209511 | |
| XARELTO | rivaroxaban | JANSSEN PHARMS | NDA022406 | |
| XARELTO | rivaroxaban | JANSSEN PHARMS | NDA202439 | |
| XARELTO | rivaroxaban | JANSSEN PHARMS | NDA215859 | |
| XARTEMIS XR | acetaminophen, oxycodone hydrochloride | MALLINCKRODT INC | NDA204031 | |
| XATMEP | methotrexate sodium | AZURITY | NDA208400 | |
| XCOPRI | cenobamate | SK LIFE | NDA212839 | |
| XDEMVY | lotilaner | TARSUS | NDA217603 | |
| XEGLYZE | abametapir | LNHC | NDA206966 | |
| XELJANZ | tofacitinib citrate | PF PRISM CV | NDA203214 | |
| XELJANZ | tofacitinib citrate | PFIZER | NDA213082 | |
| XELJANZ XR | tofacitinib citrate | PFIZER | NDA208246 | |
| XELODA | capecitabine | CHEPLAPHARM | NDA020896 | |
| XELPROS | latanoprost | SUN PHARM | NDA206185 | |
| XELSTRYM | dextroamphetamine | NOVEN PHARMS INC | NDA215401 | |
| XENAZINE | tetrabenazine | BAUSCH | NDA021894 | |
| XENICAL | orlistat | CHEPLAPHARM | NDA020766 | |
| XENLETA | lefamulin acetate | HONG KONG | NDA211672 | |
| XENLETA | lefamulin acetate | HONG KONG | NDA211673 | |
| XENON XE 127 | xenon xe-127 | MALLINCKRODT | NDA018536 | |
| XENON XE 133 | xenon xe-133 | GE HEALTHCARE | NDA017256 | |
| XENON XE 133 | xenon xe-133 | LANTHEUS MEDCL | NDA017283 | |
| XENON XE 133 | xenon xe-133 | SHINE | NDA017284 | |
| XENON XE 133 | xenon xe-133 | GEN ELECTRIC | NDA017550 | |
| XENON XE 133 | xenon xe-133 | GE HEALTHCARE | NDA017687 | |
| XENON XE 133 | xenon xe-133 | CURIUM | NDA018327 | |
| XENOVIEW | xenon xe-129 hyperpolarized | POLAREAN | NDA214375 | |
| XENPOZYME | olipudase alfa-rpcp | GENZYME CORP | BLA761261 | |
| Xeomin | incobotulinumtoxina | MERZ PHARMS | BLA125360 | |
| XEPI | ozenoxacin | LNHC | NDA208945 | |
| XERAVA | eravacycline dihydrochloride | TETRAPHASE PHARMS | NDA211109 | |
| XERESE | acyclovir, hydrocortisone | BAUSCH | NDA022436 | |
| XERMELO | telotristat etiprate | TERSERA | NDA208794 | |
| XHANCE | fluticasone propionate | PARATEK PHARMS | NDA209022 | |
| XIAFLEX | collagenase clostridium histolyticum | AUXILIUM PHARMS | BLA125338 | |
| XIFAXAN | rifaximin | SALIX PHARMS | NDA021361 | |
| XIFAXAN | rifaximin | SALIX PHARMS | NDA022554 | |
| XIFYRM | meloxicam | AZURITY | NDA218395 | |
| XIGDUO XR | dapagliflozin, metformin hydrochloride | ASTRAZENECA AB | NDA205649 | |
| XIIDRA | lifitegrast | BAUSCH AND LOMB INC | NDA208073 | |
| XIMINO | minocycline hydrochloride | JOURNEY | NDA201922 | |
| XIPERE | triamcinolone acetonide | BAUSCH AND LOMB INC | NDA211950 | |
| XOCOVA | ensitrelvir | SHIONOGI | NDA220442 | |
| XOFIGO | radium ra-223 dichloride | BAYER HLTHCARE | NDA203971 | |
| XOFLUZA | baloxavir marboxil | GENENTECH INC | NDA210854 | |
| XOFLUZA | baloxavir marboxil | GENENTECH INC | NDA214410 | |
| XOLAIR | omalizumab | GENENTECH | BLA103976 | |
| XOLEGEL | ketoconazole | INA PHARMS | NDA021946 | |
| XOLREMDI | mavorixafor | X4 PHARMS | NDA218709 | |
| XOPENEX | levalbuterol hydrochloride | HIKMA | NDA020837 | |
| XOPENEX HFA | levalbuterol tartrate | LUPIN | NDA021730 | |
| XOSPATA | gilteritinib fumarate | ASTELLAS | NDA211349 | |
| XPHOZAH | tenapanor hydrochloride | ARDELYX INC | NDA213931 | |
| XPOVIO | selinexor | KARYOPHARM THERAPS | NDA212306 | |
| XROMI | hydroxyurea | NOVA LABS LTD | NDA216593 | |
| XTAMPZA ER | oxycodone | COLLEGIUM PHARM INC | NDA208090 | |
| XTANDI | enzalutamide | ASTELLAS | NDA203415 | |
| XTANDI | enzalutamide | ASTELLAS | NDA213674 | |
| XTORO | finafloxacin | FONSECA BIOSCIENCES | NDA206307 | |
| XTRELUS | guaifenesin, hydrocodone bitartrate | ECI PHARMS LLC | NDA208085 | |
| XULTOPHY 100/3.6 | insulin degludec, liraglutide | NOVO | BLA208583 | |
| XURIDEN | uridine triacetate | BTG INTL | NDA208169 | |
| XYLOCAINE | lidocaine | ASTRAZENECA | NDA008048 | |
| XYLOCAINE | lidocaine hydrochloride | EPIC PHARMA LLC | NDA008816 | |
| XYLOCAINE | lidocaine | ASTRAZENECA | NDA013077 | |
| XYLOCAINE | lidocaine | ASTRAZENECA | NDA014127 | |
| XYLOCAINE | lidocaine | ASTRAZENECA | NDA014394 | |
| XYLOCAINE 1.5% W/ DEXTROSE 7.5% | lidocaine hydrochloride | FRESENIUS KABI USA | NDA016297 | |
| XYLOCAINE 4% PRESERVATIVE FREE | lidocaine hydrochloride | FRESENIUS KABI USA | NDA010417 | |
| XYLOCAINE 5% W/ GLUCOSE 7.5% | lidocaine hydrochloride | ASTRAZENECA | NDA010496 | |
| XYLOCAINE DENTAL | lidocaine hydrochloride | DENTSPLY PHARM | NDA021380 | |
| XYLOCAINE DENTAL WITH EPINEPHRINE | epinephrine, lidocaine hydrochloride | DENTSPLY PHARM | NDA021381 | |
| XYLOCAINE PRESERVATIVE FREE | lidocaine hydrochloride | FRESENIUS KABI USA | NDA016801 | |
| XYLOCAINE VISCOUS | lidocaine hydrochloride | FRESENIUS KABI USA | NDA009470 | |
| XYLOCAINE W/ EPINEPHRINE | epinephrine, lidocaine hydrochloride | FRESENIUS KABI USA | NDA006488 | |
| XYLOSE | xylose | LYNE | NDA018856 | |
| XYOSTED (AUTOINJECTOR) | testosterone enanthate | ANTARES PHARMA INC | NDA209863 | |
| XYREM | sodium oxybate | JAZZ PHARMS | NDA021196 | |
| XYWAV | calcium oxybate, magnesium oxybate, potassium oxybate, sodium oxybate | JAZZ | NDA212690 | |
| XYZAL | levocetirizine dihydrochloride | CHATTEM SANOFI | NDA022064 | |
| XYZAL | levocetirizine dihydrochloride | CHATTEM SANOFI | NDA022157 | |
| XYZAL ALLERGY 24HR | levocetirizine dihydrochloride | CHATTEM SANOFI | NDA209089 | |
| XYZAL ALLERGY 24HR | levocetirizine dihydrochloride | CHATTEM SANOFI | NDA209090 |