Details for New Drug Application (NDA): 212724
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The generic ingredient in PIRFENIDONE is pirfenidone. There are twenty-three drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the pirfenidone profile page.
Summary for 212724
Tradename: | PIRFENIDONE |
Applicant: | Laurus |
Ingredient: | pirfenidone |
Patents: | 0 |
Suppliers and Packaging for NDA: 212724
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PIRFENIDONE | pirfenidone | CAPSULE;ORAL | 212724 | ANDA | Laurus Labs Limited | 42385-923 | 42385-923-29 | 270 CAPSULE in 1 BOTTLE (42385-923-29) |
PIRFENIDONE | pirfenidone | CAPSULE;ORAL | 212724 | ANDA | Laurus Labs Limited | 42385-923 | 42385-923-54 | 4 BLISTER PACK in 1 CARTON (42385-923-54) / 63 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 267MG | ||||
Approval Date: | Jul 19, 2022 | TE: | AB | RLD: | No |
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