Skyla - Levonorgestrel
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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: |
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