Details for New Drug Application (NDA): 211119
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NDA 211119 describes CHOLESTYRAMINE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Ani Pharms, Endo Operations, Epic Pharma Llc, Ivax Sub Teva Pharms, Tagi, Teva, Upsher Smith Labs, Zydus Pharms, and Teva Pharms, and is included in seventeen NDAs. It is available from twelve 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. Fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the cholestyramine profile page.
Summary for 211119
| Tradename: | CHOLESTYRAMINE |
| Applicant: | Ajanta Pharma Ltd |
| Ingredient: | cholestyramine |
| Patents: | 0 |
Pharmacology for NDA: 211119
| Mechanism of Action | Bile-acid Binding Activity |
Suppliers and Packaging for NDA: 211119
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHOLESTYRAMINE | cholestyramine | POWDER;ORAL | 211119 | ANDA | Ajanta Pharma USA Inc. | 27241-134 | 27241-134-36 | 60 PACKET in 1 CARTON (27241-134-36) / 9 g in 1 PACKET (27241-134-21) |
| CHOLESTYRAMINE | cholestyramine | POWDER;ORAL | 211119 | ANDA | Ajanta Pharma USA Inc. | 27241-134 | 27241-134-51 | 378 g in 1 BOTTLE (27241-134-51) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | EQ 4GM RESIN/PACKET | ||||
| Approval Date: | Apr 6, 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: | Apr 6, 2020 | TE: | AB | RLD: | No | ||||
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