Details for New Drug Application (NDA): 212600
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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 212600
Tradename: | PIRFENIDONE |
Applicant: | Sandoz |
Ingredient: | pirfenidone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 212600
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PIRFENIDONE | pirfenidone | CAPSULE;ORAL | 212600 | ANDA | Sandoz Inc | 0781-2158 | 0781-2158-32 | 270 CAPSULE in 1 BOTTLE, PLASTIC (0781-2158-32) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 267MG | ||||
Approval Date: | Jun 13, 2022 | TE: | AB | RLD: | No |
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