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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 216285


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NDA 216285 describes DROSPIRENONE, which is a drug marketed by Exeltis Usa Inc, Lupin Ltd, Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Watson Labs, Xiromed, Apotex, Dr Reddys Labs Sa, Naari Pte Ltd, and Watson Labs Inc, and is included in twenty-one NDAs. There are fifteen patents protecting this drug. Additional details are available on the DROSPIRENONE profile page.

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:15

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength3.5MG
Approval Date:Jun 29, 2022TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 29, 2025
Regulatory Exclusivity Use:NEW PRODUCT
Patent:10,179,140Patent Expiration:Jun 28, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
Patent:10,603,281Patent Expiration:Jun 28, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE

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