Suppliers and packages for generic ingredient: DACTINOMYCIN
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DACTINOMYCIN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Recordati Rare | COSMEGEN | dactinomycin | INJECTABLE;INJECTION | 050682 | NDA | Recordati Rare Diseases, Inc. | 55292-811-55 | 12 VIAL, SINGLE-DOSE in 1 CARTON (55292-811-55) / 1 mL in 1 VIAL, SINGLE-DOSE | 1964-12-10 |
| Recordati Rare | COSMEGEN | dactinomycin | INJECTABLE;INJECTION | 050682 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-489-35 | 12 CARTON in 1 CARTON (66993-489-35) / 1 VIAL, SINGLE-DOSE in 1 CARTON (66993-489-83) / 1 mL in 1 VIAL, SINGLE-DOSE | 2017-12-04 |
| Eugia Pharma | DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 203385 | ANDA | Eugia US LLC | 55150-431-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-431-01) / 1 mL in 1 VIAL, SINGLE-DOSE | 2021-03-15 |
| Eugia Pharma | DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 203385 | ANDA | Eugia US LLC | 55150-928-02 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-928-02) / 1 mL in 1 VIAL, SINGLE-DOSE | 2021-03-15 |
| Hisun Pharm Hangzhou | DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 207232 | ANDA | Hisun Pharmaceuticals USA, Inc. | 42658-008-01 | 1 VIAL in 1 CARTON (42658-008-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 2024-05-08 |
| Meitheal | DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 213463 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-129-02 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-129-02) / 1 mL in 1 VIAL, SINGLE-DOSE | 2020-11-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
