Details for New Drug Application (NDA): 091181
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NDA 091181 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 thirteen 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.
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 091181
| Tradename: | RIFAMPIN |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | rifampin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091181
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RIFAMPIN | rifampin | INJECTABLE;INJECTION | 091181 | ANDA | Fresenius Kabi USA, LLC | 63323-351 | 63323-351-20 | 1 VIAL in 1 BOX (63323-351-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 600MG/VIAL | ||||
| Approval Date: | Aug 21, 2014 | TE: | AP | RLD: | No | ||||
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