The pill, a combination of misoprostol and mifepristone, had been pending approval by Health Canada since 2012.
It has been in use in the United States since 2000 and in France since 1988.
Vicki Saporta of the National Abortion Federation called it "great news" for women in Canada but anti-abortion campaigners disagreed, calling it a "human pesticide".
The pill causes a medically induced abortion earlier in the pregnancy than most surgical abortions. Earlier terminations are considered safer than late term abortions by pro-choice campaigners.
It is already available to women in about 60 countries, and has been in use in the UK for almost a quarter century.
Health Canada confirmed to BBC News that the Linepharma pharmaceutical company has been told they can begin production of the pill, which will be sold under the brand name Mifegymiso.
A doctor's prescription will be required for women to obtain the drug, which is normally effective up to 70 days into a pregnancy.
Mrs Saporta says the pill will likely become available in 2016, and will be distributed by doctors rather than pharmacies, as it is done in the US.
She added: "It's long overdue that Canadian women also have access to the gold standard for medical abortion care."
But Jim Hughes, national president of Campaign Life Coalition, a Canadian group opposed to abortion access, said: "RU-486 is a human pesticide which kills the pre-born child and harms women."
Abortion was first legalised by the Canadian Supreme Court in 1988.
Canadian health authorities have approved the drug RU-486, commonly known as the abortion pill.