Suppliers and packages for generic ingredient: SAPROPTERIN DIHYDROCHLORIDE
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SAPROPTERIN DIHYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Biomarin Pharm | KUVAN | sapropterin dihydrochloride | POWDER;ORAL | 205065 | NDA | BioMarin Pharmaceutical Inc. | 68135-301-22 | 30 PACKET in 1 CARTON (68135-301-22) / 1 POWDER, FOR SOLUTION in 1 PACKET (68135-301-11) | 2014-02-21 |
| Biomarin Pharm | KUVAN | sapropterin dihydrochloride | POWDER;ORAL | 205065 | NDA | BioMarin Pharmaceutical Inc. | 68135-482-11 | 30 PACKET in 1 CARTON (68135-482-11) / 1 POWDER, FOR SOLUTION in 1 PACKET (68135-482-10) | 2015-05-27 |
| Annora Pharma | SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | POWDER;ORAL | 215420 | ANDA | Camber Pharmaceuticals, Inc. | 31722-047-30 | 30 PACKET in 1 CARTON (31722-047-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-047-01) | 2022-08-18 |
| Annora Pharma | SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | POWDER;ORAL | 215420 | ANDA | Camber Pharmaceuticals, Inc. | 31722-047-31 | 1 PACKET in 1 CARTON (31722-047-31) / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-047-01) | 2022-08-18 |
| Annora Pharma | SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | POWDER;ORAL | 215420 | ANDA | Camber Pharmaceuticals, Inc. | 31722-048-30 | 30 PACKET in 1 CARTON (31722-048-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-048-01) | 2022-08-18 |
| Annora Pharma | SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | POWDER;ORAL | 215420 | ANDA | Camber Pharmaceuticals, Inc. | 31722-048-31 | 1 PACKET in 1 CARTON (31722-048-31) / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-048-01) | 2022-08-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
