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Food and Drug Administration

Reproductive Health Drugs Advisory Committee

August 29, 2006

Briefing Information

Adeza Biomedical


The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

NDA 21-945 (17 a-Hydroxyprogesterone Caproate Injection, 250 mg/mL) (pdf)

Bibliography (pdf)

Addendum/Errata (pdf)



Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §552).
These redacted portions will appear as white space on the screen or on the printed page.

Background Document (pdf)

Appendix 1 (pdf)

Bibliography (pdf)

Page last updated August 25, 2006 kkhorizonal rule
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