Details for New Drug Application (NDA): 218645
NDA 218645 describes ZELVYSIA, which is a drug marketed by Aucta and is included in one NDA. It is available from one supplier. Additional details are available on the ZELVYSIA profile page.
The generic ingredient in ZELVYSIA is sapropterin dihydrochloride. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.
The generic ingredient in ZELVYSIA is sapropterin dihydrochloride. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.
Summary for 218645
| Tradename: | ZELVYSIA |
| Applicant: | Aucta |
| Ingredient: | sapropterin dihydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 218645
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZELVYSIA | sapropterin dihydrochloride | FOR SOLUTION;ORAL | 218645 | ANDA | Aucta Pharmaceuticals, Inc. | 73289-0070 | 73289-0070-2 | 30 PACKET in 1 CARTON (73289-0070-2) / 1 POWDER, FOR SOLUTION in 1 PACKET (73289-0070-1) |
| ZELVYSIA | sapropterin dihydrochloride | FOR SOLUTION;ORAL | 218645 | ANDA | Aucta Pharmaceuticals, Inc. | 73289-0071 | 73289-0071-2 | 30 PACKET in 1 CARTON (73289-0071-2) / 1 POWDER, FOR SOLUTION in 1 PACKET (73289-0071-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 100MG/PACKET | ||||
| Approval Date: | Apr 29, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 500MG/PACKET | ||||
| Approval Date: | Apr 29, 2025 | TE: | AB | RLD: | No | ||||
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