Details for New Drug Application (NDA): 214877
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The generic ingredient in CHOLESTYRAMINE 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 214877
Tradename: | CHOLESTYRAMINE |
Applicant: | Upsher Smith Labs |
Ingredient: | cholestyramine |
Patents: | 0 |
Pharmacology for NDA: 214877
Mechanism of Action | Bile-acid Binding Activity |
Suppliers and Packaging for NDA: 214877
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CHOLESTYRAMINE | cholestyramine | POWDER;ORAL | 214877 | ANDA | Upsher-Smith Laboratories,LLC | 0832-0536 | 0832-0536-42 | 42 POUCH in 1 CARTON (0832-0536-42) / 9 g in 1 POUCH (0832-0536-89) |
CHOLESTYRAMINE | cholestyramine | POWDER;ORAL | 214877 | ANDA | Upsher-Smith Laboratories,LLC | 0832-0536 | 0832-0536-60 | 60 CAN in 1 CARTON (0832-0536-60) / 378 g in 1 CAN (0832-0536-37) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;ORAL | Strength | EQ 4GM RESIN/PACKET | ||||
Approval Date: | Jan 21, 2022 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;ORAL | Strength | EQ 4GM RESIN/SCOOPFUL | ||||
Approval Date: | Jan 21, 2022 | TE: | RLD: | No |
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