Details for New Drug Application (NDA): 075809
✉ Email this page to a colleague
The generic ingredient in ENPRESSE-28 is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 075809
Tradename: | ENPRESSE-28 |
Applicant: | Duramed Pharms Barr |
Ingredient: | ethinyl estradiol; levonorgestrel |
Patents: | 0 |
Suppliers and Packaging for NDA: 075809
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ENPRESSE-21 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-21 | 075809 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-9047 | 0555-9047-58 | 6 POUCH in 1 CARTON (0555-9047-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK |
ENPRESSE-28 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 075809 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-9047 | 0555-9047-58 | 6 POUCH in 1 CARTON (0555-9047-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-21 | Strength | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | ||||
Approval Date: | Jul 16, 2001 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | ||||
Approval Date: | Jul 16, 2001 | TE: | AB | RLD: | No |
Complete Access Available with Subscription