| Product NDC: | 68968-6675 |
| Proprietary Name: | Minivelle |
| Non Proprietary Name: | (estradiol transdermal system) |
| Active Ingredient(s): | .075 mg/1 & nbsp; (estradiol transdermal system) |
| Administration Route(s): | TRANSDERMAL |
| Dosage Form(s): | FILM, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 68968-6675 |
| Labeler Name: | Noven Therapeutics, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA203752 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20121220 |
| Package NDC: | 68968-6675-3 |
| Package Description: | 3 PACKET in 1 CARTON (68968-6675-3) > 8 POUCH in 1 PACKET > 1 FILM, EXTENDED RELEASE in 1 POUCH (68968-6675-1) |
| NDC Code | 68968-6675-3 |
| Proprietary Name | Minivelle |
| Package Description | 3 PACKET in 1 CARTON (68968-6675-3) > 8 POUCH in 1 PACKET > 1 FILM, EXTENDED RELEASE in 1 POUCH (68968-6675-1) |
| Product NDC | 68968-6675 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | (estradiol transdermal system) |
| Dosage Form Name | FILM, EXTENDED RELEASE |
| Route Name | TRANSDERMAL |
| Start Marketing Date | 20121220 |
| Marketing Category Name | NDA |
| Labeler Name | Noven Therapeutics, LLC |
| Substance Name | ESTRADIOL |
| Strength Number | .075 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] |