Details for New Drug Application (NDA): 209599
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NDA 209599 describes CHOLESTYRAMINE LIGHT, which is a drug marketed by Alkem Labs Ltd, Epic Pharma Llc, Par Pharm, 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. 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 209599
| Tradename: | CHOLESTYRAMINE LIGHT |
| Applicant: | Tagi |
| Ingredient: | cholestyramine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209599
| Mechanism of Action | Bile-acid Binding Activity |
Suppliers and Packaging for NDA: 209599
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHOLESTYRAMINE LIGHT | cholestyramine | POWDER;ORAL | 209599 | ANDA | TAGI Pharma, Inc. | 51224-009 | 51224-009-10 | 201.6 g in 1 CAN (51224-009-10) |
| CHOLESTYRAMINE LIGHT | cholestyramine | POWDER;ORAL | 209599 | ANDA | TAGI Pharma, Inc. | 51224-009 | 51224-009-20 | 60 POUCH in 1 CARTON (51224-009-20) / 4.8 g in 1 POUCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | EQ 4GM RESIN/PACKET | ||||
| Approval Date: | Nov 12, 2020 | 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 12, 2020 | TE: | AB | RLD: | No | ||||
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