Details for New Drug Application (NDA): 215534
✉ Email this page to a colleague
NDA 215534 describes SAPROPTERIN DIHYDROCHLORIDE, which is a drug marketed by Annora Pharma, Dr Reddys, and Endo Operations, and is included in eight NDAs. It is available from four 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. Five 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. Five suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.
Summary for 215534
| Tradename: | SAPROPTERIN DIHYDROCHLORIDE |
| Applicant: | Annora Pharma |
| Ingredient: | sapropterin dihydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 215534
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | TABLET;ORAL | 215534 | ANDA | Camber Pharmaceuticals, Inc. | 31722-045 | 31722-045-12 | 120 TABLET in 1 BOTTLE (31722-045-12) |
| SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | TABLET;ORAL | 215534 | ANDA | NorthStar RxLLC | 72603-191 | 72603-191-01 | 120 TABLET in 1 BOTTLE (72603-191-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Aug 23, 2022 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
