Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213171
Company: EUGIA PHARMA
Company: EUGIA PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DAPTOMYCIN | DAPTOMYCIN | 500MG/VIAL | POWDER;INTRAVENOUS | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/02/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/13/2022 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
11/13/2022 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
DAPTOMYCIN
POWDER;INTRAVENOUS; 500MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DAPTOMYCIN | DAPTOMYCIN | 500MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 211961 | ACCORD HLTHCARE |
DAPTOMYCIN | DAPTOMYCIN | 500MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 216413 | ASPIRO |
DAPTOMYCIN | DAPTOMYCIN | 500MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 212513 | BE PHARMS |
DAPTOMYCIN | DAPTOMYCIN | 500MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 217215 | BIOCON PHARMA |
DAPTOMYCIN | DAPTOMYCIN | 500MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 208375 | DR REDDYS |
DAPTOMYCIN | DAPTOMYCIN | 500MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 213171 | EUGIA PHARMA |
DAPTOMYCIN | DAPTOMYCIN | 500MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 206077 | FRESENIUS KABI USA |
DAPTOMYCIN | DAPTOMYCIN | 500MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 215890 | HAINAN POLY PHARM |
DAPTOMYCIN | DAPTOMYCIN | 500MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 215215 | HANGZHOU ZHONGMEI |
DAPTOMYCIN | DAPTOMYCIN | 500MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 212022 | HENGRUI PHARMA |
DAPTOMYCIN | DAPTOMYCIN | 500MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 212250 | HISUN PHARM HANGZHOU |
DAPTOMYCIN | DAPTOMYCIN | 500MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 213623 | MEITHEAL |
DAPTOMYCIN | DAPTOMYCIN | 500MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 213966 | MYLAN |
DAPTOMYCIN | DAPTOMYCIN | 500MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 205037 | MYLAN LABS LTD |
DAPTOMYCIN | DAPTOMYCIN | 500MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 215316 | QILU PHARM HAINAN |
DAPTOMYCIN | DAPTOMYCIN | 500MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 207104 | SAGENT PHARMS INC |
DAPTOMYCIN | DAPTOMYCIN | 500MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 091039 | TEVA PHARMS USA |
DAPTOMYCIN | DAPTOMYCIN | 500MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 206005 | XELLIA PHARMS APS |