Details for New Drug Application (NDA): 211799
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NDA 211799 describes CHOLESTYRAMINE LIGHT, which is a drug marketed by Alkem Labs Ltd, Endo Operations, Epic Pharma Llc, Macleods Pharms Ltd, Tagi, Teva, Teva Pharms, and Zydus Pharms, and is included in eight NDAs. It is available from ten suppliers. Additional details are available on the CHOLESTYRAMINE LIGHT profile page.
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.
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 211799
| Tradename: | CHOLESTYRAMINE LIGHT |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | cholestyramine |
| Patents: | 0 |
Pharmacology for NDA: 211799
| Mechanism of Action | Bile-acid Binding Activity |
Suppliers and Packaging for NDA: 211799
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHOLESTYRAMINE LIGHT | cholestyramine | POWDER;ORAL | 211799 | ANDA | Bryant Ranch Prepack | 63629-9466 | 63629-9466-1 | 60 POUCH in 1 CARTON (63629-9466-1) / 5.718 g in 1 POUCH |
| CHOLESTYRAMINE LIGHT | cholestyramine | POWDER;ORAL | 211799 | ANDA | Ascend Laboratories, LLC | 67877-422 | 67877-422-24 | 240.156 g in 1 JAR (67877-422-24) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | EQ 4GM RESIN/PACKET | ||||
| Approval Date: | Oct 19, 2021 | 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 19, 2021 | TE: | AB | RLD: | No | ||||
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