Details for New Drug Application (NDA): 022181
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The generic ingredient in KUVAN is sapropterin dihydrochloride. There are three drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.
Summary for 022181
Tradename: | KUVAN |
Applicant: | Biomarin Pharm |
Ingredient: | sapropterin dihydrochloride |
Patents: | 9 |
Suppliers and Packaging for NDA: 022181
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
KUVAN | sapropterin dihydrochloride | TABLET;ORAL | 022181 | NDA | BioMarin Pharmaceutical Inc. | 68135-300 | 68135-300-02 | 120 TABLET in 1 BOTTLE (68135-300-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Dec 13, 2007 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Try for Free | Patent Expiration: | May 16, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Try for Free | Patent Expiration: | May 17, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
Patent: | ⤷ Try for Free | Patent Expiration: | May 17, 2025 | Product Flag? | Substance Flag? | Delist Request? |
Expired US Patents for NDA 022181
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Biomarin Pharm | KUVAN | sapropterin dihydrochloride | TABLET;ORAL | 022181-001 | Dec 13, 2007 | ⤷ Try for Free | ⤷ Try for Free |
Biomarin Pharm | KUVAN | sapropterin dihydrochloride | TABLET;ORAL | 022181-001 | Dec 13, 2007 | ⤷ Try for Free | ⤷ Try for Free |
Biomarin Pharm | KUVAN | sapropterin dihydrochloride | TABLET;ORAL | 022181-001 | Dec 13, 2007 | ⤷ Try for Free | ⤷ Try for Free |
Biomarin Pharm | KUVAN | sapropterin dihydrochloride | TABLET;ORAL | 022181-001 | Dec 13, 2007 | ⤷ Try for Free | ⤷ Try for Free |
Biomarin Pharm | KUVAN | sapropterin dihydrochloride | TABLET;ORAL | 022181-001 | Dec 13, 2007 | ⤷ Try for Free | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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