Documents
Application Sponsors
| NDA 208385 | SAGENT PHARMS INC | |
Marketing Status
Application Products
| 001 | POWDER;IV (INFUSION) | 350MG/VIAL | 1 | DAPTOMYCIN | DAPTOMYCIN |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2017-09-12 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| LABELING; Labeling | SUPPL | 5 | AP | 2020-04-03 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2022-02-07 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2022-02-07 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 6 |
TE Codes
CDER Filings
SAGENT PHARMS INC
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(
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[actionDate] => 2020-04-03
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