Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075458
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ENALAPRILAT | ENALAPRILAT | 1.25MG/ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
08/22/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75456ta.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/05/2017 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
04/28/2010 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/075458s007lbl.pdf | |
06/13/2003 | SUPPL-3 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/28/2010 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/075458s007lbl.pdf |
ENALAPRILAT
INJECTABLE;INJECTION; 1.25MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ENALAPRILAT | ENALAPRILAT | 1.25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075634 | CHARTWELL INJECTABLE |
ENALAPRILAT | ENALAPRILAT | 1.25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075578 | DR REDDYS |
ENALAPRILAT | ENALAPRILAT | 1.25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078687 | HIKMA FARMACEUTICA |
ENALAPRILAT | ENALAPRILAT | 1.25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075458 | HOSPIRA |