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Details for New Drug Application (NDA): 205065
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The generic ingredient in KUVAN is sapropterin dihydrochloride. There are three drug master file entries for this compound. Additional details are available on the sapropterin dihydrochloride profile page.
Summary for 205065
Tradename: | KUVAN |
Applicant: | Biomarin Pharm |
Ingredient: | sapropterin dihydrochloride |
Patents: | 6 |
Paragraph IV (Patent) Challenges for 205065
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
KUVAN | POWDER;ORAL | sapropterin dihydrochloride | 205065 | 2017-02-23 |
KUVAN | POWDER;ORAL | sapropterin dihydrochloride | 205065 | 2015-11-09 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | 100MG/PACKET | ||||
Approval Date: | Dec 19, 2013 | TE: | AB | RLD: | Yes | ||||
Patent: | Start Trial | Patent Expiration: | May 17, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | Start Trial | Patent Expiration: | May 17, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | Start Trial | Patent Expiration: | May 17, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y |
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