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to request the commissioner of Food and Drugs to determine that Lovenox(enoxaparin sodlium),NDA 20-164(90mg/0.6ml)Product Number 006),sponsored by Aventis Pharmaceuticals Inc.(Aventis), was not withdrawn from sale for reasons of safety of effectiveness.

🏛 Food and Drug Administration (FDA)FDA-2003-P-0408

Pharmaceutical Policy

Documents

5

Total comments

0

all analyzed

Comment status

Closed

Last activity

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In this docket

Documents

Rules, notices, and supporting material — the primary rule pinned first.

All 5 Other 4 Notice 1

Other· Mar 11, 2004
Letter from FDA CDER to Olsson, Frank and Weeda, PC→
No comment period
Other· Dec 9, 2003
Letter from FDA CDER to Olsson, Frank and Weeda, P.C.→
No comment period
Other· Jun 11, 2003
Acknowledgment Letter from FDA DMB to Olsson, Frank and Weeda, P.C.→
No comment period
Other· Jun 11, 2003
Unsigned Acknowledgment Letter from FDA DMB to Olsson, Frank and Weeda, P.C.→
No comment period