Details for New Drug Application (NDA): 022474
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NDA 022474 describes ELLA, which is a drug marketed by Lab Hra Pharma and is included in one NDA. It is available from four suppliers. There are eight patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ELLA profile page.
The generic ingredient in ELLA is ulipristal acetate. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ulipristal acetate profile page.
The generic ingredient in ELLA is ulipristal acetate. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ulipristal acetate profile page.
Summary for 022474
| Tradename: | ELLA |
| Applicant: | Lab Hra Pharma |
| Ingredient: | ulipristal acetate |
| Patents: | 8 |
Pharmacology for NDA: 022474
| Mechanism of Action | Selective Progesterone Receptor Modulators |
Suppliers and Packaging for NDA: 022474
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ELLA | ulipristal acetate | TABLET;ORAL | 022474 | NDA | A-S Medication Solutions | 50090-5422 | 50090-5422-0 | 1 BLISTER PACK in 1 CARTON (50090-5422-0) / 1 TABLET in 1 BLISTER PACK |
| ELLA | ulipristal acetate | TABLET;ORAL | 022474 | NDA | RPK Pharmaceuticals, Inc. | 53002-2630 | 53002-2630-1 | 1 BLISTER PACK in 1 CARTON (53002-2630-1) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Aug 13, 2010 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Jun 24, 2024 | ||||||||
| Regulatory Exclusivity Use: | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY HRA2914-5016 | ||||||||
| Patent: | 10,159,681 | Patent Expiration: | Apr 13, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD FOR CONTRACEPTION COMPRISING THE STEP OF ORAL ADMINISTRATION A DOSAGE OF 20 MG TO 30 MG OF ULIPRISTAL ACETATE TO A WOMAN WITHIN 72 HOURS AND UP TO 120 HOURS AFTER AN UNPROTECTED INTERCOURSE | ||||||||
| Patent: | 10,772,897 | Patent Expiration: | Apr 13, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD FOR CONTRACEPTION, THE METHOD COMPRISING ADMINISTERING A TABLET COMPRISING 20 MG TO 30 MG OF ULIPRISTAL ACETATE TO A WOMAN WITHIN 120 HOURS AFTER AN UNPROTECTED INTERCOURSE | ||||||||
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