Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075458
Company: HOSPIRA

Products on ANDA 075458

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075458

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.

Labels for ANDA 075458

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

Therapeutic Equivalents for ANDA 075458

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