Details for New Drug Application (NDA): 210464
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The generic ingredient in SEVELAMER CARBONATE 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 210464
Tradename: | SEVELAMER CARBONATE |
Applicant: | Dr Reddys |
Ingredient: | sevelamer carbonate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210464
Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 210464
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SEVELAMER CARBONATE | sevelamer carbonate | FOR SUSPENSION;ORAL | 210464 | ANDA | Dr. Reddys Laboratories Inc | 43598-478 | 43598-478-90 | 90 PACKET in 1 CARTON (43598-478-90) / 1 POWDER, FOR SUSPENSION in 1 PACKET (43598-478-01) |
SEVELAMER CARBONATE | sevelamer carbonate | FOR SUSPENSION;ORAL | 210464 | ANDA | Dr. Reddys Laboratories Inc | 43598-479 | 43598-479-90 | 90 PACKET in 1 CARTON (43598-479-90) / 1 POWDER, FOR SUSPENSION in 1 PACKET (43598-479-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 800MG/PACKET | ||||
Approval Date: | Oct 25, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 2.4GM/PACKET | ||||
Approval Date: | Oct 25, 2018 | TE: | AB | RLD: | No |
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