Details for New Drug Application (NDA): 009053
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The generic ingredient in PURINETHOL is mercaptopurine. There are ten drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the mercaptopurine profile page.
Summary for 009053
Tradename: | PURINETHOL |
Applicant: | Stason Pharms |
Ingredient: | mercaptopurine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 009053
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 009053
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PURINETHOL | mercaptopurine | TABLET;ORAL | 009053 | NDA | Stason Pharmaceuticals, Inc. | 60763-601 | 60763-601-13 | 25 TABLET in 1 BOTTLE, PLASTIC (60763-601-13) |
PURINETHOL | mercaptopurine | TABLET;ORAL | 009053 | NDA AUTHORIZED GENERIC | Quinn Pharmaceuticals | 69076-913 | 69076-913-02 | 25 TABLET in 1 BOTTLE, PLASTIC (69076-913-02) |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes |
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