Details for New Drug Application (NDA): 065390
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NDA 065390 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 065390
| Tradename: | RIFAMPIN |
| Applicant: | Chartwell Molecular |
| Ingredient: | rifampin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065390
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RIFAMPIN | rifampin | CAPSULE;ORAL | 065390 | ANDA | Chartwell RX, LLC | 62135-315 | 62135-315-30 | 30 CAPSULE in 1 BOTTLE (62135-315-30) |
| RIFAMPIN | rifampin | CAPSULE;ORAL | 065390 | ANDA | Chartwell RX, LLC | 62135-316 | 62135-316-60 | 60 CAPSULE in 1 BOTTLE (62135-316-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 150MG | ||||
| Approval Date: | Mar 28, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
| Approval Date: | Mar 28, 2008 | TE: | AB | RLD: | No | ||||
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