Details for New Drug Application (NDA): 022318
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The generic ingredient in RENVELA is sevelamer carbonate. There are thirty-two drug master file entries for this compound. Twenty-eight 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 |
Formulation / Manufacturing: | see details |
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 | 022318-002 | 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 | 022318-002 | Feb 18, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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