Details for New Drug Application (NDA): 202902
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NDA 202902 describes CHOLESTYRAMINE LIGHT, which is a drug marketed by Alkem Labs Ltd, Endo Operations, Epic Pharma Llc, Tagi, Teva, Teva Pharms, and Zydus Pharms, and is included in seven 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 202902
| Tradename: | CHOLESTYRAMINE LIGHT |
| Applicant: | Zydus Pharms |
| Ingredient: | cholestyramine |
| Patents: | 0 |
Pharmacology for NDA: 202902
| Mechanism of Action | Bile-acid Binding Activity |
Suppliers and Packaging for NDA: 202902
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHOLESTYRAMINE LIGHT | cholestyramine | POWDER;ORAL | 202902 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 68382-529 | 68382-529-42 | 231 g in 1 CONTAINER (68382-529-42) |
| CHOLESTYRAMINE LIGHT | cholestyramine | POWDER;ORAL | 202902 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 68382-529 | 68382-529-60 | 60 POUCH in 1 CARTON (68382-529-60) / 5.5 g in 1 POUCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | EQ 4GM RESIN/SCOOPFUL | ||||
| Approval Date: | Apr 25, 2017 | TE: | AB | RLD: | No | ||||
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