Details for New Drug Application (NDA): 022574
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NDA 022574 describes SAFYRAL, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SAFYRAL profile page.
The generic ingredient in SAFYRAL 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 SAFYRAL 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 022574
| Tradename: | SAFYRAL |
| Applicant: | Bayer Hlthcare |
| Ingredient: | drospirenone; ethinyl estradiol; levomefolate calcium |
| Patents: | 2 |
Suppliers and Packaging for NDA: 022574
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SAFYRAL | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022574 | NDA | Sandoz Inc | 0781-4103 | 0781-4103-52 | 3 BLISTER PACK in 1 PACKAGE (0781-4103-52) / 1 KIT in 1 BLISTER PACK (0781-4103-15) |
| SAFYRAL | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022574 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-403 | 50419-403-00 | 90 BLISTER PACK in 1 PACKAGE (50419-403-00) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG | ||||
| Approval Date: | Dec 16, 2010 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Jul 17, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | PREVENTION OF PREGNANCY | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Jul 17, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | RAISE FOLATE LEVELS IN WOMEN WHO CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION FOR THE PURPOSE OF REDUCING THE RISK OF A NEURAL TUBE DEFECT IN A PREGNANCY | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Feb 8, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 022574
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | SAFYRAL | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022574-001 | Dec 16, 2010 | ⤷ Subscribe | ⤷ Subscribe |
| Bayer Hlthcare | SAFYRAL | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022574-001 | Dec 16, 2010 | ⤷ Subscribe | ⤷ Subscribe |
| Bayer Hlthcare | SAFYRAL | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022574-001 | Dec 16, 2010 | ⤷ Subscribe | ⤷ Subscribe |
| Bayer Hlthcare | SAFYRAL | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022574-001 | Dec 16, 2010 | ⤷ Subscribe | ⤷ Subscribe |
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