Ospemifene
Ospemifene is listed in the FDA National Drug Code directory with 5 NDC codes, marketed under brand name including Osphena. Available dosage forms: powder, tablet, film coated.
Drug Details
- Generic Name
- Ospemifene
- Brand Names
- Osphena
- Application Number
- NDA203505
- Sponsor
- Maithri Drugs Private Limited
- NDC Codes
- 5
- Dosage Forms
- POWDER, TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- OSPEMIFENE
Indications and Usage
1 INDICATIONS AND USAGE OSPHENA is indicated for: OSPHENA is an estrogen agonist/antagonist indicated for: The treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. ( 1.1 ) The treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause. ( 1.2 ) 1.1 The Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause. 1.2 The Treatment of Moderate to Severe Vaginal Dryness, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause.