# Effective Date of Approval of an Abbreviated New Drug Application
> **Food and Drug Administration** · Interim rule; opportunity for public comment. · Published 1998-11-05 · Effective 1998-11-10 · 63 FR 59710
## Document
- **Document number:** 98-29610
- **Category:** fda-drug
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 63 FR 59710
- **CFR reference:** 21 CFR 314
- **Publication date:** 1998-11-05
- **Effective date:** 1998-11-10
- **HHS docket:** Docket No. 85N-0214
## Abstract

The Food and Drug Administration (FDA) is issuing an interim rule to amend its regulations establishing the effective date of approval of abbreviated new drug applications (ANDA's). The interim rule eliminates the requirement that an ANDA applicant successfully defend a patent infringement suit to be eligible for 180 days of marketing exclusivity.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1998/11/05/98-29610/effective-date-of-approval-of-an-abbreviated-new-drug-application)
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