Kyleena (Page 10 of 10)
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 50419-424-011
Sterile UnitRx only
www.kyleena.com
IMPORTANT: To be inserted in the uterus by or under the supervision of a licensed clinician. See physician insert for detailed instructions for use.
Kyleena
(levonorgestrel-releasing intrauterine system)
— 19.5 mg levonorgestrel
— 1 sterile unit
— intrauterine use
| KYLEENA levonorgestrel intrauterine device | |||||||||||||||||||||
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| Labeler — Bayer HealthCare Pharmaceuticals Inc. (005436809) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Bayer Schering Pharma Oy | 369758383 | MANUFACTURE (50419-424) | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Sharp Corporation | 143696495 | RELABEL (50419-424), PACK (50419-424), REPACK (50419-424) | |
Revised: 07/2021 Bayer HealthCare Pharmaceuticals Inc.
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