# Court Decisions, ANDA Approvals, and 180-Day Exclusivity
> **Food and Drug Administration** · Interim rule; opportunity for public comment. · Published 2000-07-13 · Effective 2000-07-18 · 65 FR 43233
## Document
- **Document number:** 00-17652
- **Category:** fda-drug
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 65 FR 43233
- **CFR reference:** 21 CFR 314
- **Publication date:** 2000-07-13
- **Effective date:** 2000-07-18
- **HHS docket:** Docket No. 85N-0214
## Abstract

The Food and Drug Administration (FDA) is issuing an interim rule to amend its regulations governing the definition of court decisions that affect the timing of certain abbreviated new drug application (ANDA) approvals and the beginning of 180-day exclusivity under the Federal Food, Drug, and Cosmetic Act (the act). The interim rule eliminates the current definition of the court decision. This change is necessitated by recent court decisions on these issues.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2000/07/13/00-17652/court-decisions-anda-approvals-and-180-day-exclusivity)
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