Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207647
Company: SAVIOR LIFETEC CORP
Company: SAVIOR LIFETEC CORP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ERTAPENEM SODIUM | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, 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 |
---|---|---|---|---|---|---|---|
03/19/2019 | 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 |
---|---|---|---|---|---|
02/08/2022 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
06/09/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
ERTAPENEM SODIUM
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS; EQ 1GM BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ERTAPENEM SODIUM | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 208790 | ACS DOBFAR SPA |
ERTAPENEM SODIUM | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 209133 | EUGIA PHARMA |
ERTAPENEM SODIUM | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 212040 | GLAND PHARMA LTD |
ERTAPENEM SODIUM | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 207647 | SAVIOR LIFETEC CORP |
INVANZ | ERTAPENEM SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | Yes | AP | 021337 | MSD SUB MERCK |