Product NDC: | 68968-6637 |
Proprietary Name: | Minivelle |
Non Proprietary Name: | (estradiol transdermal system) |
Active Ingredient(s): | .0375 mg/1 & nbsp; (estradiol transdermal system) |
Administration Route(s): | TRANSDERMAL |
Dosage Form(s): | FILM, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 68968-6637 |
Labeler Name: | Noven Therapeutics, LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA203752 |
Marketing Category: | NDA |
Start Marketing Date: | 20121220 |
Package NDC: | 68968-6637-3 |
Package Description: | 3 PACKET in 1 CARTON (68968-6637-3) > 8 POUCH in 1 PACKET > 1 FILM, EXTENDED RELEASE in 1 POUCH (68968-6637-1) |
NDC Code | 68968-6637-3 |
Proprietary Name | Minivelle |
Package Description | 3 PACKET in 1 CARTON (68968-6637-3) > 8 POUCH in 1 PACKET > 1 FILM, EXTENDED RELEASE in 1 POUCH (68968-6637-1) |
Product NDC | 68968-6637 |
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 | .0375 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] |