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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 064150


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NDA 064150 describes RIFAMPIN, which is a drug marketed by Chartwell Molecular, Epic Pharma Llc, Hikma, Lupin Pharms, Avet Lifesciences, Fresenius Kabi Usa, Hikma Pharms, Mylan Labs Ltd, Watson Pharms Teva, and Hikma Intl Pharms, and is included in twelve NDAs. It is available from fourteen suppliers. Additional details are available on the RIFAMPIN profile page.

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
Formulation / Manufacturing:see details
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:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:May 28, 1997TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength150MG
Approval Date:Jan 2, 1998TE:ABRLD:No

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