Suppliers and packages for generic ingredient: SODIUM OXYBATE
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SODIUM OXYBATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Jazz Pharms | XYREM | sodium oxybate | SOLUTION;ORAL | 021196 | NDA AUTHORIZED GENERIC | Hikma Pharmaceuticals USA Inc. | 0054-9628-57 | 180 mL in 1 BOTTLE, PLASTIC (0054-9628-57) | 2023-01-03 |
| Jazz Pharms | XYREM | sodium oxybate | SOLUTION;ORAL | 021196 | NDA | Jazz Pharmaceuticals, Inc. | 68727-100-01 | 180 mL in 1 BOTTLE, PLASTIC (68727-100-01) | 2002-07-17 |
| Jazz Pharms | XYREM | sodium oxybate | SOLUTION;ORAL | 021196 | NDA AUTHORIZED GENERIC | Amneal Pharmaceuticals NY LLC | 69238-2391-1 | 180 mL in 1 BOTTLE, PLASTIC (69238-2391-1) | 2023-07-03 |
| Avadel Cns | LUMRYZ | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 214755 | NDA | Avadel CNS Pharmaceuticals, LLC | 13551-001-07 | 7 PACKET in 1 CARTON (13551-001-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET | 2023-05-01 |
| Avadel Cns | LUMRYZ | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 214755 | NDA | Avadel CNS Pharmaceuticals, LLC | 13551-001-30 | 30 PACKET in 1 CARTON (13551-001-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET | 2023-05-01 |
| Avadel Cns | LUMRYZ | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 214755 | NDA | Avadel CNS Pharmaceuticals, LLC | 13551-002-07 | 7 PACKET in 1 CARTON (13551-002-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET | 2023-05-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
