Details for New Drug Application (NDA): 077204
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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 077204
Tradename: | CHOLESTYRAMINE |
Applicant: | Endo Operations |
Ingredient: | cholestyramine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077204
Mechanism of Action | Bile-acid Binding Activity |
Suppliers and Packaging for NDA: 077204
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CHOLESTYRAMINE | cholestyramine | POWDER;ORAL | 077204 | ANDA | Par Pharmaceutical, Inc. | 49884-465 | 49884-465-65 | 60 PACKET in 1 CARTON (49884-465-65) / 9 g in 1 PACKET (49884-465-64) |
CHOLESTYRAMINE | cholestyramine | POWDER;ORAL | 077204 | ANDA | Par Pharmaceutical, Inc. | 49884-465 | 49884-465-66 | 378 g in 1 CAN (49884-465-66) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | EQ 4GM RESIN/PACKET | ||||
Approval Date: | Aug 26, 2005 | 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 26, 2005 | TE: | AB | RLD: | No |
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