Suppliers and packages for generic ingredient: pirfenidone
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pirfenidone
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Genentech Inc | ESBRIET | pirfenidone | CAPSULE;ORAL | 022535 | NDA | Genentech, Inc. | 50242-121-01 | 1 BOTTLE, PLASTIC in 1 CARTON (50242-121-01) / 270 CAPSULE in 1 BOTTLE, PLASTIC | 2014-10-15 |
| Amneal | PIRFENIDONE | pirfenidone | CAPSULE;ORAL | 212569 | ANDA | AvKARE | 42291-490-27 | 1 BOTTLE in 1 CARTON (42291-490-27) / 270 CAPSULE in 1 BOTTLE | 2023-10-18 |
| Amneal | PIRFENIDONE | pirfenidone | CAPSULE;ORAL | 212569 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1642-7 | 1 BOTTLE in 1 CARTON (60219-1642-7) / 270 CAPSULE in 1 BOTTLE | 2022-01-07 |
| Amneal | PIRFENIDONE | pirfenidone | CAPSULE;ORAL | 212569 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1642-7 | 1 BOTTLE in 1 CARTON (69238-1642-7) / 270 CAPSULE in 1 BOTTLE | 2022-01-07 |
| Laurus | PIRFENIDONE | pirfenidone | CAPSULE;ORAL | 212724 | ANDA | Laurus Labs Limited | 42385-923-29 | 270 CAPSULE in 1 BOTTLE (42385-923-29) | 2022-07-19 |
| Laurus | PIRFENIDONE | pirfenidone | CAPSULE;ORAL | 212724 | ANDA | Laurus Labs Limited | 42385-923-54 | 4 BLISTER PACK in 1 CARTON (42385-923-54) / 63 CAPSULE in 1 BLISTER PACK | 2022-07-19 |
| Laurus | PIRFENIDONE | pirfenidone | CAPSULE;ORAL | 212724 | ANDA | Laurus Labs Limited | 42385-923-63 | 2 BLISTER PACK in 1 CARTON (42385-923-63) / 21 BLISTER PACK in 1 BLISTER PACK / 42 CAPSULE in 1 BLISTER PACK | 2022-07-19 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
