Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075176
Company: HOSPIRA

Products on ANDA 75176

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Labels for ANDA 075176

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/09/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-176_Haloperidol%20Decanoate_prntlbl.pdf