Register entry

Rafa Laboratories Ltd.

Data as of · How to read this entry

Registered sites
1
Active NDC listings
4
Live patents
0
Countries
1
Base
Israel
Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1
Sites

Registered establishments

1
EstablishmentAddressRegistered forFEI / DUNS
Rafa Laboratories Ltd.3 Zeev Lev, Jerusalem, 9777515, Israel (ISR)Analytical testing, Labelling, Finished drug manufacture3004437307600024855
Catalogue

Drug listings by form and route

4

4 active NDC listings: 4 human prescription drug. By marketing category: NDA 2, UNAPPROVED DRUG OTHER 2.

Dosage formNDCs
injection3
injection, solution1
RouteNDCs
intramuscular4
Labeller name on the listingNDCs
rafa laboratories, ltd.4
Catalogue

Marketed products

4
BrandGeneric nameForm / routeNDC
-Atropine Injection, 2 mginjection, intramuscular71053-592NDA
-Atropine Sulfate Injection USP, 0.5 mg/0.7 mLinjection, intramuscular71053-590UNAPPROVED DRUG OTHER
-Atropine Sulfate Injection USP, 1 mg/0.7 mLinjection, intramuscular71053-591UNAPPROVED DRUG OTHER
-Midazolam Injection, 10 mginjection, solution, intramuscular71053-595NDA
Neighbours

Registered in the same town

1
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Comparable companies in Israel

Enquiry

Common questions

Is Rafa Laboratories Ltd. FDA approved?
Rafa Laboratories Ltd. holds 1 FDA-registered establishment in Israel. 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 Rafa Laboratories Ltd.'s drugs manufactured?
The FDA register lists Jerusalem. Registered operations: analytical testing, labelling, finished drug manufacture.
What drugs does Rafa Laboratories Ltd. make?
4 products are listed under Rafa Laboratories Ltd. in the openFDA NDC Directory, most often as injection; injection, solution. 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.