Details for New Drug Application (NDA): 090034
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NDA 090034 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 twelve 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 090034
| Tradename: | RIFAMPIN |
| Applicant: | Lupin Pharms |
| Ingredient: | rifampin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090034
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RIFAMPIN | rifampin | CAPSULE;ORAL | 090034 | ANDA | Major Pharmaceuticals | 0904-7315 | 0904-7315-61 | 100 BLISTER PACK in 1 CARTON (0904-7315-61) / 1 CAPSULE in 1 BLISTER PACK |
| RIFAMPIN | rifampin | CAPSULE;ORAL | 090034 | ANDA | A-S Medication Solutions | 50090-5709 | 50090-5709-0 | 30 CAPSULE in 1 BOTTLE (50090-5709-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 150MG | ||||
| Approval Date: | Aug 21, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
| Approval Date: | Aug 21, 2013 | TE: | AB | RLD: | No | ||||
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