Details for New Drug Application (NDA): 074558
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The generic ingredient in CHOLESTYRAMINE LIGHT 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 074558
Tradename: | CHOLESTYRAMINE LIGHT |
Applicant: | Epic Pharma Llc |
Ingredient: | cholestyramine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074558
Mechanism of Action | Bile-acid Binding Activity |
Suppliers and Packaging for NDA: 074558
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CHOLESTYRAMINE LIGHT | cholestyramine | POWDER;ORAL | 074558 | ANDA | Eon Labs, Inc. | 0185-0939 | 0185-0939-97 | 239.4 g in 1 CAN (0185-0939-97) |
CHOLESTYRAMINE LIGHT | cholestyramine | POWDER;ORAL | 074558 | ANDA | Eon Labs, Inc. | 0185-0939 | 0185-0939-98 | 60 POUCH in 1 CARTON (0185-0939-98) / 5.7 g in 1 POUCH |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | EQ 4GM RESIN/PACKET | ||||
Approval Date: | Aug 15, 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: | Aug 15, 1996 | TE: | AB | RLD: | No |
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