Suppliers and packages for generic ingredient: SEVELAMER HYDROCHLORIDE
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SEVELAMER HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Genzyme | RENAGEL | sevelamer hydrochloride | TABLET;ORAL | 021179 | NDA AUTHORIZED GENERIC | Winthrop U.S. | 0955-1048-18 | 180 TABLET, FILM COATED in 1 BOTTLE (0955-1048-18) | 2019-02-13 |
| Aurobindo Pharma Ltd | SEVELAMER HYDROCHLORIDE | sevelamer hydrochloride | TABLET;ORAL | 212599 | ANDA | Aurobindo Pharma Limited | 59651-087-36 | 360 TABLET, FILM COATED in 1 BOTTLE (59651-087-36) | 2023-07-11 |
| Aurobindo Pharma Ltd | SEVELAMER HYDROCHLORIDE | sevelamer hydrochloride | TABLET;ORAL | 212599 | ANDA | Aurobindo Pharma Limited | 59651-088-18 | 180 TABLET, FILM COATED in 1 BOTTLE (59651-088-18) | 2023-07-11 |
| Glenmark Pharms Ltd | SEVELAMER HYDROCHLORIDE | sevelamer hydrochloride | TABLET;ORAL | 204724 | ANDA | Major Pharmaceuticals | 0904-7209-06 | 50 BLISTER PACK in 1 CARTON (0904-7209-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 2024-08-19 |
| Glenmark Pharms Ltd | SEVELAMER HYDROCHLORIDE | sevelamer hydrochloride | TABLET;ORAL | 204724 | ANDA | American Health Packaging | 60687-449-01 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-449-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-449-11) | 2020-01-22 |
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