Details for New Drug Application (NDA): 207685
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NDA 207685 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 207685
| Tradename: | SAPROPTERIN DIHYDROCHLORIDE |
| Applicant: | Dr Reddys |
| Ingredient: | sapropterin dihydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207685
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | TABLET;ORAL | 207685 | ANDA | Dr. Reddys Laboratories Inc | 43598-096 | 43598-096-04 | 120 TABLET in 1 BOTTLE (43598-096-04) |
| SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | TABLET;ORAL | 207685 | ANDA | Dr. Reddys Laboratories Inc | 43598-096 | 43598-096-05 | 500 TABLET in 1 BOTTLE (43598-096-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Jun 15, 2021 | TE: | AB | RLD: | No | ||||
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