Details for New Drug Application (NDA): 203860
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NDA 203860 describes SEVELAMER CARBONATE, which is a drug marketed by Aurobindo Pharma, Bionpharma, Chartwell Rx, Dr Reddys, Impax, Invagen Pharms, Lupin Ltd, Macleods Pharms Ltd, Strides Pharma Intl, Torrent, Amneal Pharms Co, Arthur Grp, Epic Pharma Llc, Impax Labs Inc, Micro Labs, Navinta Llc, Rising, Shandong Xinhua, Strides Pharma, and Zydus Pharms, and is included in twenty-six NDAs. It is available from thirty-one 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. Thirty-three 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. Thirty-three suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.
Summary for 203860
| Tradename: | SEVELAMER CARBONATE |
| Applicant: | Invagen Pharms |
| Ingredient: | sevelamer carbonate |
| Patents: | 0 |
Pharmacology for NDA: 203860
| Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 203860
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SEVELAMER CARBONATE | sevelamer carbonate | TABLET;ORAL | 203860 | ANDA | Cipla USA Inc. | 69097-893 | 69097-893-93 | 270 TABLET, FILM COATED in 1 BOTTLE (69097-893-93) |
| SEVELAMER CARBONATE | sevelamer carbonate | TABLET;ORAL | 203860 | ANDA | Cipla USA Inc. | 69097-967 | 69097-967-93 | 270 TABLET, FILM COATED in 1 BOTTLE (69097-967-93) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
| Approval Date: | Oct 26, 2017 | TE: | AB | RLD: | No | ||||
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