Details for New Drug Application (NDA): 207200
✉ Email this page to a colleague
NDA 207200 describes SAPROPTERIN DIHYDROCHLORIDE, which is a drug marketed by Annora Pharma, Dr Reddys, and Par Pharm Inc, 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. Six 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. Six suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.
Summary for 207200
| Tradename: | SAPROPTERIN DIHYDROCHLORIDE |
| Applicant: | Par Pharm Inc |
| Ingredient: | sapropterin dihydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207200
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | TABLET;ORAL | 207200 | ANDA | Par Pharmaceutical, Inc. | 49884-720 | 49884-720-08 | 120 TABLET in 1 BOTTLE (49884-720-08) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | May 10, 2019 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
