Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075578
Company: DR REDDYS

Products on ANDA 075578

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 075578

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) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75578ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75578ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/14/2015	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
04/27/2010	SUPPL-7	Labeling		Label is not available on this site.
01/02/2004	SUPPL-3	Labeling		Label is not available on this site.
12/19/2002	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075578

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