Details for New Drug Application (NDA): 209452
✉ Email this page to a colleague
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 209452
Tradename: | SAPROPTERIN DIHYDROCHLORIDE |
Applicant: | Dr Reddys |
Ingredient: | sapropterin dihydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 209452
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | POWDER;ORAL | 209452 | ANDA | Dr. Reddys Laboratories Inc | 43598-097 | 43598-097-30 | 30 PACKET in 1 CARTON (43598-097-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (43598-097-11) |
SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | POWDER;ORAL | 209452 | ANDA | Dr. Reddys Laboratories Inc | 43598-477 | 43598-477-30 | 30 PACKET in 1 CARTON (43598-477-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (43598-477-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | 100MG/PACKET | ||||
Approval Date: | Mar 30, 2021 | TE: | AB | RLD: | No |
Complete Access Available with Subscription