Details for New Drug Application (NDA): 209374
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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-six suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.
Summary for 209374
Tradename: | SEVELAMER CARBONATE |
Applicant: | Bionpharma |
Ingredient: | sevelamer carbonate |
Patents: | 0 |
Pharmacology for NDA: 209374
Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 209374
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SEVELAMER CARBONATE | sevelamer carbonate | FOR SUSPENSION;ORAL | 209374 | ANDA | Bionpharma Inc. | 69452-126 | 69452-126-19 | 90 PACKET in 1 CARTON (69452-126-19) / 1 POWDER, FOR SUSPENSION in 1 PACKET (69452-126-60) |
SEVELAMER CARBONATE | sevelamer carbonate | FOR SUSPENSION;ORAL | 209374 | ANDA | Bionpharma Inc. | 69452-127 | 69452-127-19 | 90 PACKET in 1 CARTON (69452-127-19) / 1 POWDER, FOR SUSPENSION in 1 PACKET (69452-127-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 800MG/PACKET | ||||
Approval Date: | May 17, 2021 | TE: | AB | RLD: | No |
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