Details for New Drug Application (NDA): 077075
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NDA 077075 describes GILDESS FE 1.5/30, which is a drug marketed by Endo Operations and is included in one NDA. Additional details are available on the GILDESS FE 1.5/30 profile page.
The generic ingredient in GILDESS FE 1.5/30 is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
The generic ingredient in GILDESS FE 1.5/30 is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 077075
| Tradename: | GILDESS FE 1.5/30 |
| Applicant: | Endo Operations |
| Ingredient: | ethinyl estradiol; norethindrone acetate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-28 | Strength | 0.03MG;1.5MG | ||||
| Approval Date: | Apr 28, 2005 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-21 | Strength | 0.03MG;1.5MG | ||||
| Approval Date: | Jul 24, 2012 | TE: | RLD: | No | |||||
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