Details for New Drug Application (NDA): 209109
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NDA 209109 describes CHOLESTYRAMINE LIGHT, which is a drug marketed by Alkem Labs Ltd, Epic Pharma Llc, Macleods Pharms Ltd, Ph Health, Pharmobedient Cnsltg, Teva, Teva Pharms, and Zydus Pharms, and is included in eight NDAs. It is available from eleven 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. Fifteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the cholestyramine profile page.
Summary for 209109
| Tradename: | CHOLESTYRAMINE LIGHT |
| Applicant: | Macleods Pharms Ltd |
| Ingredient: | cholestyramine |
| Patents: | 0 |
Pharmacology for NDA: 209109
| Mechanism of Action | Bile-acid Binding Activity |
Suppliers and Packaging for NDA: 209109
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHOLESTYRAMINE LIGHT | cholestyramine | POWDER;ORAL | 209109 | ANDA | Macleods Pharmaceuticals Limited | 33342-319 | 33342-319-70 | 60 POUCH in 1 CARTON (33342-319-70) / 5.7 g in 1 POUCH (33342-319-01) |
| CHOLESTYRAMINE LIGHT | cholestyramine | POWDER;ORAL | 209109 | ANDA | Macleods Pharmaceuticals Limited | 33342-319 | 33342-319-72 | 42 POUCH in 1 CARTON (33342-319-72) / 5.7 g in 1 POUCH (33342-319-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;ORAL | Strength | EQ 4GM RESIN/SCOOPFUL | ||||
| Approval Date: | Oct 31, 2024 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;ORAL | Strength | EQ 4GM RESIN/PACKET | ||||
| Approval Date: | Oct 31, 2024 | TE: | RLD: | No | |||||
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