Details for New Drug Application (NDA): 021065
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NDA 021065 describes FEMHRT, which is a drug marketed by Apil and is included in one NDA. Additional details are available on the FEMHRT profile page.
The generic ingredient in FEMHRT 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 FEMHRT 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 021065
| Tradename: | FEMHRT |
| Applicant: | Apil |
| Ingredient: | ethinyl estradiol; norethindrone acetate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.0025MG;0.5MG | ||||
| Approval Date: | Jan 14, 2005 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 15, 1999 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 021065
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Apil | FEMHRT | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 021065-001 | Jan 14, 2005 | 5,208,225 | ⤷ Subscribe |
| Apil | FEMHRT | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 021065-002 | Oct 15, 1999 | 5,208,225 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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