Details for New Drug Application (NDA): 207294
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NDA 207294 describes CHOLESTYRAMINE, which is a drug marketed by Aiping Pharm Inc, Ajanta Pharma Ltd, Alkem Labs Ltd, Ani Pharms, Epic Pharma Llc, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Micro Labs, Ph Health, Pharmobedient, Teva, Zydus Pharms, Pharmobedient Cnsltg, and Teva Pharms, and is included in twenty NDAs. It is available from thirteen suppliers. Additional details are available on the CHOLESTYRAMINE profile page.
The generic ingredient in CHOLESTYRAMINE is cholestyramine. There are eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the cholestyramine profile page.
The generic ingredient in CHOLESTYRAMINE is cholestyramine. There are eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the cholestyramine profile page.
Summary for 207294
| Tradename: | CHOLESTYRAMINE |
| Applicant: | Macleods Pharms Ltd |
| Ingredient: | cholestyramine |
| Patents: | 0 |
Pharmacology for NDA: 207294
| Mechanism of Action | Bile-acid Binding Activity |
Suppliers and Packaging for NDA: 207294
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHOLESTYRAMINE | cholestyramine | POWDER;ORAL | 207294 | ANDA | Macleods Pharmaceuticals Limited | 33342-293 | 33342-293-70 | 60 POUCH in 1 CARTON (33342-293-70) / 9 g in 1 POUCH (33342-293-75) |
| CHOLESTYRAMINE | cholestyramine | POWDER;ORAL | 207294 | ANDA | Macleods Pharmaceuticals Limited | 33342-293 | 33342-293-71 | 378 g in 1 JAR (33342-293-71) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | EQ 4GM RESIN/PACKET | ||||
| Approval Date: | Nov 21, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | EQ 4GM RESIN/SCOOPFUL | ||||
| Approval Date: | Nov 21, 2024 | TE: | AB | RLD: | No | ||||
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