Details for New Drug Application (NDA): 207200
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The generic ingredient in SAPROPTERIN DIHYDROCHLORIDE is sapropterin dihydrochloride. There are three drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.
Summary for 207200
Tradename: | SAPROPTERIN DIHYDROCHLORIDE |
Applicant: | Par Pharm Inc |
Ingredient: | sapropterin dihydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 207200
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | TABLET;ORAL | 207200 | ANDA | Par Pharmaceutical, Inc. | 49884-720 | 49884-720-08 | 120 TABLET in 1 BOTTLE (49884-720-08) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | May 10, 2019 | TE: | AB | RLD: | No |
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