Agency Information Collection Activities; Submission for OMB Review; Comment Request; Guidance for Industry; Changes to an Approved NDA or ANDA.  (21DEC00)
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SangStat Medical Corp.; Withdrawal of Approval of an Abbreviated New Drug Application; Cyclosporine.  (04DEC00)
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Draft Guidance for Industry on Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications; Availability. (26OCT00)
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The Draft Guidance

Apothecon, Inc., et al.; Withdrawal of Approval of 76 Abbreviated New Drug Applications. (02OCT00)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Changes to an Approved NDA or ANDA. (07SEP00)
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Court Decisions, ANDA Approvals, and 180-Day Exclusivity. (13JUL00)
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Certain Single-Entity Coronary Vasodilators Containing Isosorbide Dinitrate; Withdrawal of Approval of Abbreviated New Drug Applications. (07JUL00)
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Agency Information Collection Activities; Announcement of OMB Approval; Changes to an Approved NDA or ANDA. (05JUN00)
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Plans to Develop Guidance on Submitting an Archival Copy of an ANDA in Electronic Format; Request for Comments.  (27JAN00)
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