Details for New Drug Application (NDA): 212674
✉ Email this page to a colleague
The generic ingredient in PIRFENIDONE is pirfenidone. There are twenty-three drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the pirfenidone profile page.
Summary for 212674
Tradename: | PIRFENIDONE |
Applicant: | Hetero Labs Ltd V |
Ingredient: | pirfenidone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 212674
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PIRFENIDONE | pirfenidone | TABLET;ORAL | 212674 | ANDA | Camber Pharmaceuticals, Inc. | 31722-872 | 31722-872-27 | 3 BOTTLE in 1 CARTON (31722-872-27) / 90 TABLET, FILM COATED in 1 BOTTLE (31722-872-90) |
PIRFENIDONE | pirfenidone | TABLET;ORAL | 212674 | ANDA | Camber Pharmaceuticals, Inc. | 31722-873 | 31722-873-90 | 90 TABLET, FILM COATED in 1 BOTTLE (31722-873-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 267MG | ||||
Approval Date: | Sep 21, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 801MG | ||||
Approval Date: | Sep 21, 2022 | TE: | AB | RLD: | No |
Complete Access Available with Subscription