Suppliers and packages for generic ingredient: darunavir
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darunavir
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Janssen Prods | PREZISTA | darunavir | SUSPENSION;ORAL | 202895 | NDA | Janssen Products LP | 59676-565-01 | 1 BOTTLE, GLASS in 1 CARTON (59676-565-01) / 200 mL in 1 BOTTLE, GLASS | 2011-12-16 |
| Amneal | DARUNAVIR | darunavir | TABLET;ORAL | 212493 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1144-6 | 1 BOTTLE, PLASTIC in 1 CARTON (60219-1144-6) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2023-12-09 |
| Amneal | DARUNAVIR | darunavir | TABLET;ORAL | 212493 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1145-3 | 1 BOTTLE, PLASTIC in 1 CARTON (60219-1145-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2023-12-09 |
| Aurobindo Pharma Ltd | DARUNAVIR | darunavir | TABLET;ORAL | 210677 | ANDA | Aurobindo Pharma Limited | 59651-085-60 | 60 TABLET, FILM COATED in 1 BOTTLE (59651-085-60) | 2023-11-28 |
| Aurobindo Pharma Ltd | DARUNAVIR | darunavir | TABLET;ORAL | 210677 | ANDA | Aurobindo Pharma Limited | 59651-086-30 | 30 TABLET, FILM COATED in 1 BOTTLE (59651-086-30) | 2023-11-28 |
| Cipla | DARUNAVIR | darunavir | TABLET;ORAL | 206288 | ANDA | American Health Packaging | 60687-808-21 | 30 BLISTER PACK in 1 CARTON (60687-808-21) / 1 TABLET in 1 BLISTER PACK (60687-808-11) | 2024-06-09 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
