Is Jewoo Medical CO.,LTD FDA approved?

Jewoo Medical CO.,LTD holds 1 FDA-registered establishment in South Korea. 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 Jewoo Medical CO.,LTD's drugs manufactured?

The FDA register lists Seoul 04808. Registered operations: finished drug manufacture.

What drugs does Jewoo Medical CO.,LTD make?

3 products are listed under Jewoo Medical CO.,LTD in the openFDA NDC Directory, most often as paste, dentifrice. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Jewoo Medical CO.,LTD

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

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Registered sites: 1
Active NDC listings: 3
Live patents: 0
Countries: 1
Base: South Korea

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Jewoo Medical CO.,LTD	287 Garam-gil, Seongdong-gu, Seoul, Seoul 04808, Korea, South (KOR)	Finished drug manufacture	3012161326689512541

Catalogue

Drug listings by form and route

3 active NDC listings: 3 human otc drug. By marketing category: UNAPPROVED DRUG OTHER 3.

Dosage form	NDCs
paste, dentifrice	3

Route	NDCs
dental	3

Labeller name on the listing	NDCs
jewoo medical co.,ltd	3

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
BIS II Tooth	Precipitated Calcium Carbonate, Tocopherol Acetate, Aluminium Chlorohydroxy Allantoinate, Dibasic Calcium Phosphate Hydrate	paste, dentifrice, dental	69653-200UNAPPROVED DRUG OTHER
BIS II Tooth	Precipitated Calcium Carbonate, Tocopherol Acetate, Aluminium Chlorohydroxy Allantoinate, Dibasic Calcium Phosphate Hydrate	paste, dentifrice, dental	69653-201UNAPPROVED DRUG OTHER
BIS II Tooth	Precipitated Calcium Carbonate, Tocopherol Acetate, Aluminium Chlorohydroxy Allantoinate, Dibasic Calcium Phosphate Hydrate	paste, dentifrice, dental	69653-202UNAPPROVED DRUG OTHER

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Enquiry

Common questions

Is Jewoo Medical CO.,LTD FDA approved?: Jewoo Medical CO.,LTD holds 1 FDA-registered establishment in South Korea. 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 Jewoo Medical CO.,LTD's drugs manufactured?: The FDA register lists Seoul 04808. Registered operations: finished drug manufacture.
What drugs does Jewoo Medical CO.,LTD make?: 3 products are listed under Jewoo Medical CO.,LTD in the openFDA NDC Directory, most often as paste, dentifrice. 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.