Suppliers and packagers for generic pharmaceutical drug: BUDESONIDE
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BUDESONIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Padagis Israel | BUDESONIDE | budesonide | AEROSOL, FOAM;RECTAL | 215328 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-627-86 | 2 CANISTER in 1 CARTON (45802-627-86) / 1 AEROSOL, FOAM in 1 CANISTER (45802-627-01) | 2023-04-17 |
| Salix | UCERIS | budesonide | AEROSOL, FOAM;RECTAL | 205613 | NDA | Salix Pharmaceuticals, Inc. | 65649-651-03 | 2 CANISTER in 1 CARTON (65649-651-03) / 1 AEROSOL, FOAM in 1 CANISTER (65649-651-02) | 2014-12-01 |
| Salix | UCERIS | budesonide | AEROSOL, FOAM;RECTAL | 205613 | NDA | Oceanside Pharmaceuticals | 68682-658-03 | 2 CANISTER in 1 CARTON (68682-658-03) / 1 AEROSOL, FOAM in 1 CANISTER (68682-658-02) | 2022-07-15 |
| Amneal Pharms | BUDESONIDE | budesonide | CAPSULE, DELAYED RELEASE;ORAL | 206200 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-778-10 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (53746-778-10) | 2025-05-22 |
| Amneal Pharms | BUDESONIDE | budesonide | CAPSULE, DELAYED RELEASE;ORAL | 206200 | ANDA | Bryant Ranch Prepack | 63629-8294-1 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-8294-1) | 2017-09-15 |
| Amneal Pharms | BUDESONIDE | budesonide | CAPSULE, DELAYED RELEASE;ORAL | 206200 | ANDA | Amneal Pharmaceuticals LLC | 65162-778-10 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-778-10) | 2017-09-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
