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Generated: May 28, 2017
| Tradename: | 1 |
| Applicant: | 1 |
| Ingredient: | 1 |
| Patents: | 1 |
| Therapeutic Class: | Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers) |
| Formulation / Manufacturing: | see details |
| Ingredient-type | Estradiol Congeners |
| Mechanism of Action | Estrogen Receptor Agonists |
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
VAGIFEM |
estradiol |
TABLET;VAGINAL | 020908 | NDA | Novo Nordisk | 0169-5176 | 0169-5176-03 | 8 APPLICATOR in 1 CARTON (0169-5176-03) > 1 INSERT in 1 APPLICATOR |
VAGIFEM |
estradiol |
TABLET;VAGINAL | 020908 | NDA | Novo Nordisk | 0169-5176 | 0169-5176-04 | 18 APPLICATOR in 1 CARTON (0169-5176-04) > 1 INSERT in 1 APPLICATOR |
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;VAGINAL | Strength | 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
| Approval Date: | Mar 26, 1999 | TE: | RLD: | Yes | |||||
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;VAGINAL | Strength | 10MCG | ||||
| Approval Date: | Nov 25, 2009 | TE: | AB | RLD: | Yes | ||||
| Patent: | 5,860,946 | Patent Expiration: | Jul 1, 2017 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 7,018,992 | Patent Expiration: | Sep 17, 2022 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ATROPHIC VAGINITIS DUE TO MENOPAUSE | ||||||||
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