Details for New Drug Application (NDA): 040594
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NDA 040594 describes MERCAPTOPURINE, which is a drug marketed by Dr Reddys Labs Sa, Hikma, and Mylan, and is included in three NDAs. It is available from two suppliers. Additional details are available on the MERCAPTOPURINE profile page.
The generic ingredient in MERCAPTOPURINE is mercaptopurine. There are ten drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the mercaptopurine profile page.
The generic ingredient in MERCAPTOPURINE is mercaptopurine. There are ten drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the mercaptopurine profile page.
Summary for 040594
| Tradename: | MERCAPTOPURINE |
| Applicant: | Mylan |
| Ingredient: | mercaptopurine |
| Patents: | 0 |
Pharmacology for NDA: 040594
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 040594
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MERCAPTOPURINE | mercaptopurine | TABLET;ORAL | 040594 | ANDA | Mylan Pharmaceuticals Inc. | 0378-3547 | 0378-3547-25 | 250 TABLET in 1 BOTTLE, PLASTIC (0378-3547-25) |
| MERCAPTOPURINE | mercaptopurine | TABLET;ORAL | 040594 | ANDA | Mylan Pharmaceuticals Inc. | 0378-3547 | 0378-3547-52 | 25 TABLET in 1 BOTTLE, PLASTIC (0378-3547-52) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jul 1, 2005 | TE: | AB | RLD: | No | ||||
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