Details for New Drug Application (NDA): 022127
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NDA 022127 describes RENVELA, which is a drug marketed by Genzyme and Sanofi and is included in two NDAs. It is available from two suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the RENVELA profile page.
The generic ingredient in RENVELA is sevelamer carbonate. There are thirty-two drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.
The generic ingredient in RENVELA is sevelamer carbonate. There are thirty-two drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.
Summary for 022127
| Tradename: | RENVELA |
| Applicant: | Sanofi |
| Ingredient: | sevelamer carbonate |
| Patents: | 1 |
Pharmacology for NDA: 022127
| Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 022127
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RENVELA | sevelamer carbonate | TABLET;ORAL | 022127 | NDA AUTHORIZED GENERIC | Winthrop U.S, a business of sanofi-aventis U.S. LLC | 0955-1050 | 0955-1050-27 | 270 TABLET, FILM COATED in 1 BOTTLE (0955-1050-27) |
| RENVELA | sevelamer carbonate | TABLET;ORAL | 022127 | NDA AUTHORIZED GENERIC | Winthrop U.S, a business of sanofi-aventis U.S. LLC | 0955-1057 | 0955-1057-30 | 270 TABLET, FILM COATED in 1 BOTTLE (0955-1057-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
| Approval Date: | Oct 19, 2007 | TE: | AB | RLD: | Yes | ||||
| Patent: | 7,985,418 | Patent Expiration: | Oct 27, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 022127
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sanofi | RENVELA | sevelamer carbonate | TABLET;ORAL | 022127-001 | Oct 19, 2007 | 7,014,846 | ⤷ Subscribe |
| Sanofi | RENVELA | sevelamer carbonate | TABLET;ORAL | 022127-001 | Oct 19, 2007 | 5,496,545 | ⤷ Subscribe |
| Sanofi | RENVELA | sevelamer carbonate | TABLET;ORAL | 022127-001 | Oct 19, 2007 | 7,459,151 | ⤷ Subscribe |
| Sanofi | RENVELA | sevelamer carbonate | TABLET;ORAL | 022127-001 | Oct 19, 2007 | 6,858,203 | ⤷ Subscribe |
| Sanofi | RENVELA | sevelamer carbonate | TABLET;ORAL | 022127-001 | Oct 19, 2007 | 6,509,013 | ⤷ Subscribe |
| Sanofi | RENVELA | sevelamer carbonate | TABLET;ORAL | 022127-001 | Oct 19, 2007 | 5,667,775 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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