2004P-0390
C 1
Volume 2

Comment

Appendix A - Docket No. 2004P-0390, Suitability Petition Submitted by Lachman
Consultant Services, Inc. on August 31, 2004

Attachment A - page 3-135 of the 24th edition of the Approved Drug Products with Therapeutic Equivalence Evaluations

Attachment B - Proposed Labeling

Attachment C - Doryx (RLD) Labeling

Appendix B - Orange Book listing for Doxycycline Hyclate

Appendix C - Labeling for Vibra-Tabs (doxycycline hyclate film coated tablets, Pfizer Labs, NDA 50-533)

Appendix D - Docket Nos. 01P-0515/CP1 and 01P-0109/CP1