Details for New Drug Application (NDA): 073263
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NDA 073263 describes PREVALITE, which is a drug marketed by Upsher Smith Labs and is included in one NDA. It is available from one supplier. Additional details are available on the PREVALITE profile page.
The generic ingredient in PREVALITE is cholestyramine. There are eight drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the cholestyramine profile page.
The generic ingredient in PREVALITE is cholestyramine. There are eight drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the cholestyramine profile page.
Summary for 073263
| Tradename: | PREVALITE |
| Applicant: | Upsher Smith Labs |
| Ingredient: | cholestyramine |
| Patents: | 0 |
Pharmacology for NDA: 073263
| Mechanism of Action | Bile-acid Binding Activity |
Suppliers and Packaging for NDA: 073263
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PREVALITE | cholestyramine | POWDER;ORAL | 073263 | ANDA | Upsher-Smith Laboratories, LLC | 0245-0036 | 0245-0036-23 | 231 g in 1 CAN (0245-0036-23) |
| PREVALITE | cholestyramine | POWDER;ORAL | 073263 | ANDA | Upsher-Smith Laboratories, LLC | 0245-0036 | 0245-0036-42 | 42 PACKET in 1 CARTON (0245-0036-42) / 5.5 g in 1 PACKET (0245-0036-89) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | EQ 4GM RESIN/PACKET | ||||
| Approval Date: | Feb 22, 1996 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | EQ 4GM RESIN/SCOOPFUL | ||||
| Approval Date: | Oct 30, 1997 | TE: | AB | RLD: | No | ||||
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