Details for New Drug Application (NDA): 075809
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NDA 075809 describes ENPRESSE-28, which is a drug marketed by Duramed Pharms Barr and is included in one NDA. Additional details are available on the ENPRESSE-28 profile page.
The generic ingredient in ENPRESSE-28 is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
The generic ingredient in ENPRESSE-28 is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three 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 |
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 | ||||
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