Details for New Drug Application (NDA): 216418
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NDA 216418 describes MERCAPTOPURINE, which is a drug marketed by Hikma, Dr Reddys Labs Sa, and Mylan, and is included in four 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 216418
| Tradename: | MERCAPTOPURINE |
| Applicant: | Hikma |
| Ingredient: | mercaptopurine |
| Patents: | 0 |
Pharmacology for NDA: 216418
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 216418
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MERCAPTOPURINE | mercaptopurine | SUSPENSION;ORAL | 216418 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0879 | 0054-0879-49 | 1 BOTTLE, GLASS in 1 CARTON (0054-0879-49) / 100 mL in 1 BOTTLE, GLASS |
| MERCAPTOPURINE | mercaptopurine | SUSPENSION;ORAL | 216418 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-4582 | 0054-4582-49 | 1 BOTTLE, GLASS in 1 CARTON (0054-4582-49) / 100 mL in 1 BOTTLE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 20MG/ML | ||||
| Approval Date: | Feb 26, 2025 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Aug 25, 2025 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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