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Regulations
Federal Register, November 01, 2002
Human drugs: day generic drug exclusivity; withdrawn,
Proposed rules
... 67, Number 212)] [Proposed Rules] [Page 66593-66594] gov] [DOCID:fr01no02-32] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug 21 CFR Part [Docket No. 85N-......4 85N-0214] 180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications SUMMARY: The Food and Drug Administration (FDA) is announcing the ...
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Regulations
Federal Register, August 06, 1999
Human drugs: day generic drug exclusivity,
Proposed rules
... 64, Number 151)] [Proposed Rules] [Page 42873-42887] gov] [DOCID:fr06au99-27] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug 21 CFR Part [Docket No. 85N-...... CFR Part 314 85N-0214] 180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications SUMMARY: The Food and Drug Administration (FDA) is proposing to amend its ...
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News and Business
Saturday Evening Post - Vol. 280 Nbr. 5, September 2008
* Trouble Switching to Generic Drug: To S.M., N. Mankato, Minnesota: You report ...... Our nation's laws require that all drugs (both trade name and generic) meet the same ...... In addition, the generic product must be similar in the way that it works,...
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Atrix Laboratories Inc., Fort Collins, announced it has received approval from the U.S. Food and Drug Administration for Atrix's abbreviated new drug ...
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News and Business
Global Finance - Vol. 23 Nbr. 9, October 2009
Hyderabad-based Dr. Reddy's Laboratories, India's second-biggest pharmaceutical company, is a major global supplier of generic drugs. It has developed a strategic plan to ...... Reddy's generic drugs in emerging market countries, excluding ...
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News and Business
Business Wire - June 24, 1999
IVAX Announces Generic Drug Approval for Cimetidine and Two Tentative Generic Approvals.
MIAMI--(BUSINESS WIRE)--June 24, 1999-- IVAX Corporation (AMEX:IVX) today announced that the United States Food and Drug Administration (FDA) has approved its ...... Cimetidine is indicated in the treatment of heartburn associated with acid indigestion and sour stomach, and is the generic equivalent of SmithKline Beecham's Tagamet(R) ...
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Legal Books and Journals
United States Law Articles in English - (June 23, 2003)
Bush Proposal May Facilitate Generic Drug Entry
Dr. Yin Zhang PhD - Testa, Hurwitz & Thibeault, LLP
In October, 2002, President Bush issued proposed revisions to the FDA regulations governing generic drug market entry. The proposed regulations ("...... elicited mixed responses from various pioneer and generic drug manufacturers, healthcare providers, and ...
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News and Business
Business Wire - October 12, 2009
NEW YORK -- Reportlinker.com announces that a new market research report is available in its catalogue. Generic Drug Market in Canada http://www.reportlinker....... in Canada html Canada represents one of the largest markets for pharmaceuticals in the world, with a huge potential for generics. In 2008, generics accounted for more than 51% ...
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Business Editors MIAMI--(BUSINESS WIRE)--Feb. 24, 2000 IVAX Corporation (AMEX:IVX) today announced that the United States Food and Drug Administration (FDA) has given tentative ...... Enalapril maleate tablets are the generic equivalent of Merck and Company's Vasotec(R), ...
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News and Business
Mondaq Business Briefing - Nbr. 2003, May 2003
In October, 2002, President Bush issued proposed revisions to the FDA regulations governing generic drug market entry. The proposed regulations ("...... elicited mixed responses from various pioneer and generic drug manufacturers, healthcare providers, and ...
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