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Skyla
Skyla - 50419-422-01 - (Levonorgestrel)
Drug Information of Skyla
| Product NDC: | 50419-422 |
| Proprietary Name: | Skyla |
| Non Proprietary Name: | Levonorgestrel |
| Active Ingredient(s): | 13.5 mg/1 & nbsp; Levonorgestrel |
| Administration Route(s): | INTRAUTERINE |
| Dosage Form(s): | INTRAUTERINE DEVICE |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Skyla
| Product NDC: | 50419-422 |
| Labeler Name: | Bayer HealthCare Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA203159 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20130111 |
Package Information of Skyla
| Package NDC: | 50419-422-01 |
| Package Description: | 1 INTRAUTERINE DEVICE in 1 CARTON (50419-422-01) |
NDC Information of Skyla
| NDC Code | 50419-422-01 |
| Proprietary Name | Skyla |
| Package Description | 1 INTRAUTERINE DEVICE in 1 CARTON (50419-422-01) |
| Product NDC | 50419-422 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Levonorgestrel |
| Dosage Form Name | INTRAUTERINE DEVICE |
| Route Name | INTRAUTERINE |
| Start Marketing Date | 20130111 |
| Marketing Category Name | NDA |
| Labeler Name | Bayer HealthCare Pharmaceuticals Inc. |
| Substance Name | LEVONORGESTREL |
| Strength Number | 13.5 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] |
