Details for New Drug Application (NDA): 206094
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NDA 206094 describes SEVELAMER CARBONATE, which is a drug marketed by Aurobindo Pharma, Bionpharma, Chartwell Rx, Dr Reddys, Impax, Lupin Ltd, Strides Pharma, Amneal Pharms Co, Anxin, Arthur Grp, Impax Labs Inc, Invagen Pharms, Macleods Pharms Ltd, Micro Labs, Rising, and Zydus Pharms, and is included in twenty NDAs. It is available from twenty-five suppliers. Additional details are available on the SEVELAMER CARBONATE profile page.
The generic ingredient in SEVELAMER CARBONATE is sevelamer carbonate. There are thirty-two drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.
The generic ingredient in SEVELAMER CARBONATE is sevelamer carbonate. There are thirty-two drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.
Summary for 206094
| Tradename: | SEVELAMER CARBONATE |
| Applicant: | Dr Reddys |
| Ingredient: | sevelamer carbonate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206094
| Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 206094
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SEVELAMER CARBONATE | sevelamer carbonate | TABLET;ORAL | 206094 | ANDA | Major Pharmaceuticals | 0904-6707 | 0904-6707-06 | 50 BLISTER PACK in 1 CARTON (0904-6707-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| SEVELAMER CARBONATE | sevelamer carbonate | TABLET;ORAL | 206094 | ANDA | Major Pharmaceuticals | 0904-6707 | 0904-6707-82 | 100 BLISTER PACK in 1 CARTON (0904-6707-82) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
| Approval Date: | Sep 29, 2017 | TE: | AB | RLD: | No | ||||
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