Details for New Drug Application (NDA): 050627
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NDA 050627 describes RIFADIN, which is a drug marketed by Sanofi Aventis Us and is included in three NDAs. It is available from one supplier. Additional details are available on the RIFADIN profile page.
The generic ingredient in RIFADIN is rifampin. There are nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the rifampin profile page.
The generic ingredient in RIFADIN is rifampin. There are nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the rifampin profile page.
Summary for 050627
| Tradename: | RIFADIN |
| Applicant: | Sanofi Aventis Us |
| Ingredient: | rifampin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 050627
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RIFADIN | rifampin | INJECTABLE;INJECTION | 050627 | NDA | Sanofi-Aventis U.S. LLC | 0068-0597 | 0068-0597-01 | 1 VIAL, GLASS in 1 CARTON (0068-0597-01) / 10 mL in 1 VIAL, GLASS |
| RIFADIN | rifampin | INJECTABLE;INJECTION | 050627 | NDA | Sanofi-Aventis U.S. LLC | 0068-0599 | 0068-0599-01 | 1 VIAL, GLASS in 1 CARTON (0068-0599-01) / 10 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 600MG/VIAL | ||||
| Approval Date: | May 25, 1989 | TE: | AP | RLD: | Yes | ||||
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