Details for New Drug Application (NDA): 217042
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NDA 217042 describes RIFAPENTINE, which is a drug marketed by Macleods Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the RIFAPENTINE profile page.
The generic ingredient in RIFAPENTINE is rifapentine. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the rifapentine profile page.
The generic ingredient in RIFAPENTINE is rifapentine. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the rifapentine profile page.
Summary for 217042
| Tradename: | RIFAPENTINE |
| Applicant: | Macleods Pharms |
| Ingredient: | rifapentine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 217042
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RIFAPENTINE | rifapentine | TABLET;ORAL | 217042 | ANDA | Macleods Pharmaceuticals Limited | 33342-599 | 33342-599-54 | 3 BLISTER PACK in 1 CARTON (33342-599-54) / 8 TABLET, FILM COATED in 1 BLISTER PACK (33342-599-20) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Jun 23, 2026 | TE: | AB | RLD: | No | ||||
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