Conjugated Estrogens

 

• FDA's Position on Approvability of a Synthetic Generic Version of Premarin - Letter from Dr. Janet Woodcock, Director FDA/CDER (May 5, 1997)

• FDA Background Information on Conjugated Estrogens (last updated 7/2005)

• Conjugated Estrogens Monograph Materials submitted to the United States Pharmacopeia "Committee of Revision" for consideration for adoption:

1. Transmittal letter proposing the establishment of new monographs for "Synthetic Conjugated Estrogens, USP" and "Synthetic Conjugated Estrogens Tablets, USP" along with the proposed monographs (PDF - 304KB) (2000)

2. Transmittal letter proposing revisions to the current USP 24 monograph for "Conjugated Estrogens" along with the proposed monograph (PDF - 268KB) (2000)