Is Oncora Pharma, LLC FDA approved?

Oncora Pharma, LLC holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Oncora Pharma, LLC's registered sites?

The FDA register lists Dallas, TX. Registered operations: labelling, repackaging.

What drugs does Oncora Pharma, LLC make?

43 products are listed under Oncora Pharma, LLC in the openFDA NDC Directory, most often as tablet; gel; cream. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Oncora Pharma, LLC

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 43
Labeller names: 2
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Labelling1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Oncora Pharma, LLLCRegistrant: Oncora Pharma, LLC	12015 Shiloh Rd Ste 120, Dallas, Texas (TX) 75228-1551, United States (USA)	Labelling, Repackaging	3037141727119482542

Catalogue

Drug listings by form and route

43 active NDC listings: 37 human prescription drug, 6 human otc drug. By marketing category: UNAPPROVED DRUG OTHER 35, OTC MONOGRAPH DRUG 6, ANDA 2.

Dosage form	NDCs
tablet	14
gel	9
cream	7
capsule	6
liquid	1
lotion	1
patch	1
solution	1
spray	1
tablet, chewable	1
tablet, coated	1

Route	NDCs
oral	23
topical	20

Labeller name on the listing	NDCs
oncora pharma, llc	42
oncora pharma llc	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Aflora	Multivitamin	tablet, oral	85477-904UNAPPROVED DRUG OTHER
Bionara ULTRA	Probiotic Dietary Supplement Capsules	capsule, oral	85477-710UNAPPROVED DRUG OTHER
Collavera	Collavera	gel, topical	85477-305UNAPPROVED DRUG OTHER
DERMACURE	Urea 41%	cream, topical	85477-909UNAPPROVED DRUG OTHER
Embriva	ASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, POTASSIUM IODIDE	tablet, oral	85477-322UNAPPROVED DRUG OTHER
Evara	Urea 40.5 Cream	cream, topical	85477-308UNAPPROVED DRUG OTHER
Folartex	Multivitamin	tablet, oral	85477-511UNAPPROVED DRUG OTHER
Folaten	Multivitamin	tablet, oral	85477-901UNAPPROVED DRUG OTHER
Folixia	Multivitamin	tablet, oral	85477-902UNAPPROVED DRUG OTHER
Foltira	Folate, Vitamin D3	tablet, oral	85477-921UNAPPROVED DRUG OTHER
Folvyris	Folate, Vitamin D3	tablet, oral	85477-823UNAPPROVED DRUG OTHER
Folyra	Multivitamin	tablet, oral	85477-523UNAPPROVED DRUG OTHER
Gestyra	ASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, POTASSIUM IODIDE	tablet, oral	85477-922UNAPPROVED DRUG OTHER
Hydralyn	Hydralyn	gel, topical	85477-316UNAPPROVED DRUG OTHER
Hydravex	Hydravex	gel, topical	85477-310UNAPPROVED DRUG OTHER
Hydroxym	HYDROCORTISONE	gel, topical	85477-309UNAPPROVED DRUG OTHER
Ketoprofen	Ketoprofen	capsule, oral	85477-111ANDA
Lidexa	Lidexa	cream, topical	85477-330UNAPPROVED DRUG OTHER
LidexaGel 5%	Lidocaine HCl	gel, topical	85477-730UNAPPROVED DRUG OTHER
LidoSpra	LidoSpra	spray, topical	85477-325UNAPPROVED DRUG OTHER
Lidocaine 4% Patch	Lidocaine 4%	patch, topical	85477-302OTC MONOGRAPH DRUG
Lidomar	Lidomar	lotion, topical	85477-326OTC MONOGRAPH DRUG
Lidomax	Lidomax	gel, topical	85477-304UNAPPROVED DRUG OTHER
Lidovara	Lidovara	gel, topical	85477-303UNAPPROVED DRUG OTHER
Lumavex	Multivitamin	capsule, oral	85477-610UNAPPROVED DRUG OTHER
Lunavira	Multivitamin	capsule, oral	85477-623UNAPPROVED DRUG OTHER
METAVEX	METAVEX	tablet, oral	85477-503UNAPPROVED DRUG OTHER
METHYL SALICYLATE 25%	METHYL SALICYLATE	cream, topical	85477-301OTC MONOGRAPH DRUG
METHYL SALICYLATE 25%	METHYL SALICYLATE	cream, topical	85477-311OTC MONOGRAPH DRUG
Methenamine Mandelate	Methenamine Mandelate	solution, oral	85477-115UNAPPROVED DRUG OTHER
Methocarbamol	Methocarbamol	tablet, coated, oral	85477-101ANDA
Microvara	Probiotic Dietary Supplement	capsule, oral	85477-711UNAPPROVED DRUG OTHER
Minovia Mini	Minovia Mini	tablet, oral	85477-924UNAPPROVED DRUG OTHER
Mirexa Mini	Mirexa Mini	tablet, oral	85477-925UNAPPROVED DRUG OTHER
Numyra	Numyra	gel, topical	85477-312UNAPPROVED DRUG OTHER
Nutralyn	Multivitamin	tablet, oral	85477-903UNAPPROVED DRUG OTHER
Probentra	Probiotic Dietary Supplement Capsules	capsule, oral	85477-712UNAPPROVED DRUG OTHER
Tolfyra	Tolnaftate	liquid, topical	85477-331OTC MONOGRAPH DRUG
Topicaine Ultra	Topicaine Ultra	gel, topical	85477-307OTC MONOGRAPH DRUG
Urea 41	Urea 41	cream, topical	85477-306UNAPPROVED DRUG OTHER
Urea 41%	Urea	cream, topical	85477-905UNAPPROVED DRUG OTHER
Virexa	Vitamin C, Vitamin D3, Vitamin B1, Vitamin B6, Vitamin B12, Folic Acid, NADH, Ubiquinone	tablet, oral	85477-606UNAPPROVED DRUG OTHER
Vitavera	Vitavera	tablet, chewable, oral	85477-513UNAPPROVED DRUG OTHER

Neighbours

Registered in the same town

Eisinger Smith LLCDallas, TX · 2 sites
PETNET Solutions, Inc.DALLAS, TX
Cardinal Health 418, Inc.Dallas, TX
SOFIE Co. dba SOFIEDallas, TX
Univar Solutions USA LLCDallas, TX
Reed Baileydallas, TX
Dhaliwal Pharmaceuticals Laboratories LLCDallas, TX
Aloe Vera Of America IncDallas, TX
Bond Pharmacy INCDallas, TX
Gleeco Labs LLCDallas, TX
MEDWISE LIFESCIENCES INC.Dallas, TX
McKinley Resources Inc.Dallas, TX

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Enquiry

Common questions

Is Oncora Pharma, LLC FDA approved?: Oncora Pharma, LLC holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Oncora Pharma, LLC's registered sites?: The FDA register lists Dallas, TX. Registered operations: labelling, repackaging.
What drugs does Oncora Pharma, LLC make?: 43 products are listed under Oncora Pharma, LLC in the openFDA NDC Directory, most often as tablet; gel; cream. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.