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Details for New Drug Application (NDA): 020908
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NDA 020908 describes VAGIFEM, which is a drug marketed by Novo Nordisk Inc and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the VAGIFEM profile page.
The generic ingredient in VAGIFEM is estradiol. There are seventy-five drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the estradiol profile page.
The generic ingredient in VAGIFEM is estradiol. There are seventy-five drug master file entries for this compound. Forty-one 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 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020908
| 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 | 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 |
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| Dosage: | TABLET;VAGINAL | Strength | 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||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: | Start Trial | 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 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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