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Skyla - Levonorgestrel

Navigation: NDC > Supplier starting with: B > BAYER HEALTHCARE PHARMACEUTICALS INC.
Field Value
NDC Code: 50419-422
Proprietary Name: Skyla
Suffix:
Non-Proprietary Name: Levonorgestrel
Dosage Form: INTRAUTERINE DEVICE
Method: INTRAUTERINE
Original Marketing Date: 11-01-2013
Category Name: NDA
Application Number: NDA203159
Labeler: BAYER HEALTHCARE PHARMACEUTICALS INC.
Substance Name: LEVONORGESTREL
Active Numerator Strength: 13.5
Active Ingredient Unit: mg/1
Pharm Classes: Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC]
DEA Schedule: