Details for New Drug Application (NDA): 212709
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The generic ingredient in PIRFENIDONE is pirfenidone. There are twenty-three drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the pirfenidone profile page.
Summary for 212709
Tradename: | PIRFENIDONE |
Applicant: | Apotex |
Ingredient: | pirfenidone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 212709
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PIRFENIDONE | pirfenidone | TABLET;ORAL | 212709 | ANDA | Golden State Medical Supply, Inc. | 51407-913 | 51407-913-27 | 270 TABLET in 1 BOTTLE (51407-913-27) |
PIRFENIDONE | pirfenidone | TABLET;ORAL | 212709 | ANDA | Golden State Medical Supply, Inc. | 51407-914 | 51407-914-90 | 90 TABLET in 1 BOTTLE (51407-914-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 267MG | ||||
Approval Date: | May 31, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 801MG | ||||
Approval Date: | May 31, 2023 | TE: | AB | RLD: | No |
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