Details for New Drug Application (NDA): 216285
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NDA 216285 describes DROSPIRENONE, which is a drug marketed by Exeltis Usa Inc, Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Mylan Labs Ltd, Watson Labs, Apotex, Dr Reddys Labs Sa, Lupin Ltd, Naari Pte Ltd, and Watson Labs Inc, and is included in twenty NDAs. There are thirteen 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.
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: | 13 |
| Formulation / Manufacturing: | see details |
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: | ⤷ Try a Trial | Patent Expiration: | Jun 28, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE | ||||||||
| Patent: | ⤷ Try a Trial | 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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