Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213786
Company: MEITHEAL
Company: MEITHEAL
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 |
---|---|---|---|---|---|---|---|
06/29/2021 | 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 |
---|---|---|---|---|---|
03/22/2023 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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 | 213396 | FRESENIUS KABI USA |
DAPTOMYCIN | DAPTOMYCIN | 350MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 213786 | MEITHEAL |
DAPTOMYCIN | DAPTOMYCIN | 350MG/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AP | 208385 | SAGENT PHARMS INC |