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Details for New Drug Application (NDA): 211367
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NDA 211367 describes SLYND, which is a drug marketed by Exeltis Usa Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the SLYND profile page.
The generic ingredient in SLYND is drospirenone. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the drospirenone profile page.
The generic ingredient in SLYND is drospirenone. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the drospirenone profile page.
Summary for 211367
| Tradename: | SLYND |
| Applicant: | Exeltis Usa Inc |
| Ingredient: | drospirenone |
| Patents: | 4 |
| Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 211367
Generic Entry Date for 211367*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 211367
Suppliers and Packaging for NDA: 211367
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SLYND | drospirenone | TABLET;ORAL | 211367 | NDA | Exeltis USA, Inc. | 0642-7470 | 0642-7470-02 | 1 BLISTER PACK in 1 CARTON (0642-7470-02) > 28 TABLET, FILM COATED in 1 BLISTER PACK (0642-7470-01) |
| SLYND | drospirenone | TABLET;ORAL | 211367 | NDA | Exeltis USA, Inc. | 0642-7470 | 0642-7470-03 | 3 BLISTER PACK in 1 CARTON (0642-7470-03) > 28 TABLET, FILM COATED in 1 BLISTER PACK (0642-7470-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
| Approval Date: | May 23, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 23, 2022 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | Start Trial | Patent Expiration: | Jun 28, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE | ||||||||
| Patent: | Start Trial | Patent Expiration: | Jun 8, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE | ||||||||
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