Details for New Drug Application (NDA): 214912
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NDA 214912 describes SODIUM POLYSTYRENE SULFONATE, which is a drug marketed by Ajenat Pharms, Chartwell Rx, Citrusphrma, Cmp Pharma Inc, Epic Pharma Llc, Nuvo Pharms Inc, Pai Holdings Pharm, Upsher Smith Labs, Ani Pharms, Hikma, Lyne, Morton Grove, and Roxane, and is included in thirteen NDAs. It is available from nine suppliers. Additional details are available on the SODIUM POLYSTYRENE SULFONATE profile page.
The generic ingredient in SODIUM POLYSTYRENE SULFONATE is sodium polystyrene sulfonate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the sodium polystyrene sulfonate profile page.
The generic ingredient in SODIUM POLYSTYRENE SULFONATE is sodium polystyrene sulfonate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the sodium polystyrene sulfonate profile page.
Summary for 214912
| Tradename: | SODIUM POLYSTYRENE SULFONATE |
| Applicant: | Lyne |
| Ingredient: | sodium polystyrene sulfonate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 214912
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM POLYSTYRENE SULFONATE | sodium polystyrene sulfonate | SUSPENSION;ORAL, RECTAL | 214912 | ANDA | Burel Pharmaceuticals, LLC | 35573-108 | 35573-108-14 | 10 BOTTLE, UNIT-DOSE in 1 CARTON (35573-108-14) / 60 mL in 1 BOTTLE, UNIT-DOSE (35573-108-13) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL, RECTAL | Strength | 15GM/60ML | ||||
| Approval Date: | Jun 10, 2025 | TE: | AA | RLD: | No | ||||
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