Details for New Drug Application (NDA): 064150
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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 064150
Tradename: | RIFAMPIN |
Applicant: | Epic Pharma Llc |
Ingredient: | rifampin |
Patents: | 0 |
Suppliers and Packaging for NDA: 064150
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RIFAMPIN | rifampin | CAPSULE;ORAL | 064150 | ANDA | Eon Labs, Inc. | 0185-0799 | 0185-0799-01 | 100 CAPSULE in 1 BOTTLE (0185-0799-01) |
RIFAMPIN | rifampin | CAPSULE;ORAL | 064150 | ANDA | Eon Labs, Inc. | 0185-0799 | 0185-0799-05 | 500 CAPSULE in 1 BOTTLE (0185-0799-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
Approval Date: | May 28, 1997 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 150MG | ||||
Approval Date: | Jan 2, 1998 | TE: | AB | RLD: | No |
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