Details for New Drug Application (NDA): 075405
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The generic ingredient in CLADRIBINE is cladribine. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the cladribine profile page.
Summary for 075405
Tradename: | CLADRIBINE |
Applicant: | Hikma |
Ingredient: | cladribine |
Patents: | 0 |
Suppliers and Packaging for NDA: 075405
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLADRIBINE | cladribine | INJECTABLE;INJECTION | 075405 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9871 | 0143-9871-01 | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9871-01) / 10 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
Approval Date: | Feb 28, 2000 | TE: | AP | RLD: | No |
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