Food and Drug
Reproductive Health Drugs
August 29, 2006
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)
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)