CONTENTS
PREFACE TO THIRTY SECOND EDITION………… ………… …………
..…................
iv
2
HOW TO USE THE DRUG PRODUCTS LISTS
..............................................................
2-1
2.1
Key Sections for Using the Drug Product Lists …………………….….………………
......
2-1
2.2
Drug Product Illustration ……………………………………………
..….…………….……..
2-3
2.3
Therapeutic Equivalence Evaluations Illustration ………………….….…………..………2-4 DRUG PRODUCT LISTS
Prescription Drug Product List ……………………………………….…………….………………
...
3-1
OTC Drug Product List ……………………………………………….…………….…………………4-1
Drug Products with Approval under Section 505 of the Act Administered
Drug Products Which Must Demonstrate in vivo Bioavailability
by the Center for Biologics Evaluation and Research List
...……….…….………………...
5-1
Discontinued Drug Product List .…………………………………………….…….………………
....
6-1
Orphan Products Designations and Approvals List …………….………….…….………………
..
7-1
Only if Product Fails to Achieve Adequate Dissolution …………………
..………………………..
8-1
APPENDICES
A.
Product Name Index ……….…...………………………….………..……………………A-1 B. Product Name Index Listed by Applicant ………………….……
..……………………..
B-1
C.
Uniform Terms …………………………………………….………
..…………...………...
C-1
PATENT AND EXCLUSIVITY INFORMATION ADDENDUM ……….……..………………..........AD1
A.
Patent and Exclusivity Lists …………………………….…
..……..……………..……ADA1
B.
Patent and Exclusivity Terms
...……………………….….………...…………………ADB1
..…................
iv
2
HOW TO USE THE DRUG PRODUCTS LISTS
..............................................................
2-1
2.1
Key Sections for Using the Drug Product Lists …………………….….………………
......
2-1
2.2
Drug Product Illustration ……………………………………………
..….…………….……..
2-3
2.3
Therapeutic Equivalence Evaluations Illustration ………………….….…………..………2-4 DRUG PRODUCT LISTS
Prescription Drug Product List ……………………………………….…………….………………
...
3-1
OTC Drug Product List ……………………………………………….…………….…………………4-1
Drug Products with Approval under Section 505 of the Act Administered
Drug Products Which Must Demonstrate in vivo Bioavailability
by the Center for Biologics Evaluation and Research List
...……….…….………………...
5-1
Discontinued Drug Product List .…………………………………………….…….………………
....
6-1
Orphan Products Designations and Approvals List …………….………….…….………………
..
7-1
Only if Product Fails to Achieve Adequate Dissolution …………………
..………………………..
8-1
APPENDICES
A.
Product Name Index ……….…...………………………….………..……………………A-1 B. Product Name Index Listed by Applicant ………………….……
..……………………..
B-1
C.
Uniform Terms …………………………………………….………
..…………...………...
C-1
PATENT AND EXCLUSIVITY INFORMATION ADDENDUM ……….……..………………..........AD1
A.
Patent and Exclusivity Lists …………………………….…
..……..……………..……ADA1
B.
Patent and Exclusivity Terms
...……………………….….………...…………………ADB1