What does ZC Orange Book rating mean?
What does ZC Orange Book rating mean?
single source products
ZC – single source products which appear in the Orange Book, but are. not rated (e.g., brand products with no generics available)
What is a Orange Book rating?
The publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act) and related patent and …
Is B an Orange Book rating?
The Orange Book Codes supply the FDA’s therapeutic equivalence rating for applicable multi-source categories….Orange Book Codes.
| Code | Interpretation |
|---|---|
| BT | Topical product with bioequivalence issues |
| BX | Insufficient data to confirm bioequivalence |
| B* | Requires further FDA investigation and review |
What is the TE code in Orange Book?
Therapeutic Equivalence codes
The Orange Book uses Therapeutic Equivalence codes (TE codes) a short series of letters and sometimes numbers (eg AB, AB2, BX) to categorize drugs based upon their assessed equivalency.
What is the obc3 code for the Orange Book?
OBC3 – Orange Book Code; 3-Byte Version A three-character alphanumeric column that identifies the equivalency ratings assigned to approved prescription products according to the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). The source is First Databank.
What are the requirements for the Orange Book?
The Hatch-Waxman Amendments require that FDA, among other things, make publicly available a list of approved drug products with monthly supplements. The Orange Book and its monthly Cumulative Supplements satisfy this requirement.
What is the Orange Book and what does it mean?
The publication, Approved Drug Products With Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Why are tentative approvals not included in the Orange Book?
Under the FD&C Act, some drug products are given tentative approvals. The Agency will not include drug products with tentative approvals in the Orange Book because a drug product that is granted tentative approval is not an approved drug product. Tentative approval lists by month are available on FDA’s website Drugs@FDA .