Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212667
Company: ACCORD HLTHCARE
Company: ACCORD HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DAPTOMYCIN | DAPTOMYCIN | 350MG/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 |
---|---|---|---|---|---|---|---|
07/12/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212667Orig1s000ltr.pdf |
DAPTOMYCIN
POWDER;INTRAVENOUS; 350MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DAPTOMYCIN | DAPTOMYCIN | 350MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 212667 | ACCORD HLTHCARE |
DAPTOMYCIN | DAPTOMYCIN | 350MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 216445 | ASPIRO |
DAPTOMYCIN | DAPTOMYCIN | 350MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 213425 | BE PHARMS |
DAPTOMYCIN | DAPTOMYCIN | 350MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 211403 | DR REDDYS |
DAPTOMYCIN | DAPTOMYCIN | 350MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 213786 | MEITHEAL |
DAPTOMYCIN | DAPTOMYCIN | 350MG/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AP | 208385 | SAGENT PHARMS INC |