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 three 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. Three 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. Three 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 | RedPharm Drug, Inc | 67296-1466 | 67296-1466-1 | 1 TABLET in 1 BOTTLE (67296-1466-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Aug 13, 2010 | TE: | AB | RLD: | Yes | ||||
| 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 | ||||||||
| Patent: | 8,426,392 | Patent Expiration: | Jun 12, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ELLA IS A PROGESTERONE AGONIST/ANTAGONIST EMERGENCY CONTRACEPTION INDICATED FOR THE PREVENTION OF PREGNANCY FOLLOWING UNPROTECTED INTERCOURSE OR A KNOWN OR SUSPECTED CONTRACEPTIVE FAILURE. ELLA CAN BE TAKEN WITH OR WITHOUT FOOD | ||||||||
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