Details for New Drug Application (NDA): 215798
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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 215798
Tradename: | SAPROPTERIN DIHYDROCHLORIDE |
Applicant: | Dr Reddys |
Ingredient: | sapropterin dihydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 215798
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | POWDER;ORAL | 215798 | ANDA | Dr. Reddys Laboratories Inc | 43598-162 | 43598-162-30 | 30 PACKET in 1 CARTON (43598-162-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (43598-162-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | 500MG/PACKET | ||||
Approval Date: | May 13, 2022 | TE: | AB | RLD: | No |
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