Details for New Drug Application (NDA): 212570
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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 212570
Tradename: | PIRFENIDONE |
Applicant: | Amneal |
Ingredient: | pirfenidone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 212570
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PIRFENIDONE | pirfenidone | TABLET;ORAL | 212570 | ANDA | AvKARE | 42291-491 | 42291-491-27 | 3 BOTTLE in 1 CARTON (42291-491-27) / 90 TABLET, FILM COATED in 1 BOTTLE (42291-491-09) |
PIRFENIDONE | pirfenidone | TABLET;ORAL | 212570 | ANDA | AvKARE | 42291-492 | 42291-492-09 | 1 BOTTLE in 1 CARTON (42291-492-09) / 90 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 267MG | ||||
Approval Date: | Mar 25, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 801MG | ||||
Approval Date: | Mar 25, 2022 | TE: | AB | RLD: | No |
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