# 180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/180-day-generic-drug-exclusivity-under-the-hatch-waxman-amendments-to-the-federal-food-drug-and-cosmetic-act/99b50bce-632e-41dc-871f-60d4142d9386

> FDA guidance document: 180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. Issue date: June 01, 1998. Get complete insights and analysis.

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## Details

- Title: 180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 1998-06-01
- Last Changed: 2020-04-21
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-1998-D-101c">FDA-1998-D-101c</a>

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