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Details for New Drug Application (NDA): 020908
The generic ingredient in VAGIFEM is estradiol. There are seventy-five drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the estradiol profile page.
Summary for 020908
Tradename: | VAGIFEM |
Applicant: | Novo Nordisk Inc |
Ingredient: | estradiol |
Patents: | 1 |
Therapeutic Class: | Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers) |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020908
Ingredient-type | Estradiol Congeners |
Mechanism of Action | Estrogen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 020908
Suppliers and Packaging for NDA: 020908
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VAGIFEM | estradiol | TABLET;VAGINAL | 020908 | NDA | Novo Nordisk | 0169-5176 | N | 0169-5176-03 |
VAGIFEM | estradiol | TABLET;VAGINAL | 020908 | NDA | Novo Nordisk | 0169-5176 | N | 0169-5176-99 |
Profile for product number 001
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| Dosage: | TABLET;VAGINAL | Strength | 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||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 |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;VAGINAL | Strength | 10MCG | ||||
Approval Date: | Nov 25, 2009 | TE: | AB | RLD: | Yes | ||||
Patent: | ➤ Sign Up | Patent Expiration: | Sep 17, 2022 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF ATROPHIC VAGINITIS DUE TO MENOPAUSE |
Expired US Patents for NDA 020908
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novo Nordisk Inc | VAGIFEM | estradiol | TABLET;VAGINAL | 020908-002 | Nov 25, 2009 | ➤ Sign Up | ➤ Sign Up |
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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