Details for New Drug Application (NDA): 022318
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NDA 022318 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-seven 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-seven suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.
Summary for 022318
| Tradename: | RENVELA |
| Applicant: | Genzyme |
| Ingredient: | sevelamer carbonate |
| Patents: | 1 |
Pharmacology for NDA: 022318
| Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 022318
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318 | NDA AUTHORIZED GENERIC | Winthrop U.S, a business of sanofi-aventis U.S. LLC | 0955-1052 | 0955-1052-90 | 90 PACKET in 1 BOX (0955-1052-90) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0955-1052-01) |
| RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318 | NDA AUTHORIZED GENERIC | Winthrop U.S, a business of sanofi-aventis U.S. LLC | 0955-1054 | 0955-1054-90 | 90 PACKET in 1 BOX (0955-1054-90) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0955-1054-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 800MG/PACKET | ||||
| Approval Date: | Aug 12, 2009 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 6, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 2.4GM/PACKET | ||||
| Approval Date: | Feb 18, 2009 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 6, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 022318
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-001 | Aug 12, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-002 | Feb 18, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-002 | Feb 18, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-002 | Feb 18, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-001 | Aug 12, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-001 | Aug 12, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Genzyme | RENVELA | sevelamer carbonate | FOR SUSPENSION;ORAL | 022318-001 | Aug 12, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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