Suppliers and packages for generic ingredient: CYSTEAMINE BITARTRATE
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CYSTEAMINE BITARTRATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Horizon | PROCYSBI | cysteamine bitartrate | CAPSULE, DELAYED RELEASE;ORAL | 203389 | NDA | Horizon Therapeutics USA, Inc. | 75987-100-04 | 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (75987-100-04) | 2013-04-30 |
| Horizon | PROCYSBI | cysteamine bitartrate | CAPSULE, DELAYED RELEASE;ORAL | 203389 | NDA | Horizon Therapeutics USA, Inc. | 75987-101-08 | 250 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (75987-101-08) | 2013-04-30 |
| Mylan | CYSTAGON | cysteamine bitartrate | CAPSULE;ORAL | 020392 | NDA | Mylan Pharmaceuticals Inc. | 0378-9040-05 | 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9040-05) | 2005-04-11 |
| Mylan | CYSTAGON | cysteamine bitartrate | CAPSULE;ORAL | 020392 | NDA | Mylan Pharmaceuticals Inc. | 0378-9045-05 | 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9045-05) | 2005-04-11 |
| Horizon | PROCYSBI | cysteamine bitartrate | GRANULE, DELAYED RELEASE;ORAL | 213491 | NDA | Horizon Therapeutics USA, Inc. | 75987-140-13 | 60 PACKET in 1 CARTON (75987-140-13) / 1 GRANULE, DELAYED RELEASE in 1 PACKET | 2020-02-14 |
| Horizon | PROCYSBI | cysteamine bitartrate | GRANULE, DELAYED RELEASE;ORAL | 213491 | NDA | Horizon Therapeutics USA, Inc. | 75987-140-14 | 120 PACKET in 1 CARTON (75987-140-14) / 1 GRANULE, DELAYED RELEASE in 1 PACKET | 2020-02-14 |
| Horizon | PROCYSBI | cysteamine bitartrate | GRANULE, DELAYED RELEASE;ORAL | 213491 | NDA | Horizon Therapeutics USA, Inc. | 75987-145-13 | 60 PACKET in 1 CARTON (75987-145-13) / 1 GRANULE, DELAYED RELEASE in 1 PACKET | 2020-02-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
