Details for New Drug Application (NDA): 216285
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The generic ingredient in DROSPIRENONE is drospirenone; ethinyl estradiol; levomefolate calcium. There are eleven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol; levomefolate calcium profile page.
Summary for 216285
Tradename: | DROSPIRENONE |
Applicant: | Exeltis Usa Inc |
Ingredient: | drospirenone |
Patents: | 14 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 3.5MG | ||||
Approval Date: | Jun 29, 2022 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Jun 29, 2025 | ||||||||
Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 28, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 28, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE |
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