Details for New Drug Application (NDA): 216797
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NDA 216797 describes SAPROPTERIN DIHYDROCHLORIDE, which is a drug marketed by Annora Pharma, Dr Reddys, Hopewell Pharma, Ph Health, Aurobindo Pharma, and Zenara, and is included in eleven NDAs. It is available from seven suppliers. Additional details are available on the SAPROPTERIN DIHYDROCHLORIDE profile page.
The generic ingredient in SAPROPTERIN DIHYDROCHLORIDE is sapropterin dihydrochloride. There are three drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.
The generic ingredient in SAPROPTERIN DIHYDROCHLORIDE is sapropterin dihydrochloride. There are three drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.
Summary for 216797
| Tradename: | SAPROPTERIN DIHYDROCHLORIDE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | sapropterin dihydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216797
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | TABLET;ORAL | 216797 | ANDA | Aurobindo Pharma Limited | 59651-574 | 59651-574-08 | 120 TABLET in 1 BOTTLE (59651-574-08) |
| SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | TABLET;ORAL | 216797 | ANDA | Aurobindo Pharma Limited | 59651-574 | 59651-574-24 | 240 TABLET in 1 BOTTLE (59651-574-24) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Jun 9, 2025 | TE: | AB | RLD: | No | ||||
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