Details for New Drug Application (NDA): 205039
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The generic ingredient in RIFAMPIN is isoniazid; rifampin. There are five drug master file entries for this compound. Additional details are available on the isoniazid; rifampin profile page.
Summary for 205039
Tradename: | RIFAMPIN |
Applicant: | Hikma Pharms |
Ingredient: | rifampin |
Patents: | 0 |
Suppliers and Packaging for NDA: 205039
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RIFAMPIN | rifampin | INJECTABLE;INJECTION | 205039 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9230 | 0143-9230-01 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9230-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 600MG/VIAL | ||||
Approval Date: | Mar 3, 2016 | TE: | AP | RLD: | No |
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