Details for New Drug Application (NDA): 040028
NDA 040028 describes KIONEX, which is a drug marketed by Ani Pharms and is included in two NDAs. It is available from one supplier. Additional details are available on the KIONEX profile page.
The generic ingredient in KIONEX is sodium polystyrene sulfonate. There is one drug master file entry for this compound. Eleven suppliers are listed for this compound. Additional details are available on the sodium polystyrene sulfonate profile page.
The generic ingredient in KIONEX is sodium polystyrene sulfonate. There is one drug master file entry for this compound. Eleven suppliers are listed for this compound. Additional details are available on the sodium polystyrene sulfonate profile page.
Summary for 040028
| Tradename: | KIONEX |
| Applicant: | Ani Pharms |
| Ingredient: | sodium polystyrene sulfonate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 040028
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KIONEX | sodium polystyrene sulfonate | SUSPENSION;ORAL, RECTAL | 040028 | ANDA | ANI Pharmaceuticals, Inc. | 62559-356 | 62559-356-01 | 10 BOTTLE in 1 CASE (62559-356-01) / 60 mL in 1 BOTTLE (62559-356-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL, RECTAL | Strength | 15GM/60ML | ||||
| Approval Date: | Sep 17, 2007 | TE: | AA | RLD: | No | ||||
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