# ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/andaspharmaceutical-solid-polymorphism-chemistry-manufacturing-and-controls-information-guidance-for-industry/ea6f758d-a4f3-4afe-b529-2949f9e35169

> FDA guidance document: ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information:  Guidance for Industry. Issue date: July 09, 2007. Get complete insights and analysis.

---

## Details

- Title: ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information:  Guidance for Industry
- 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: 2007-07-09
- Last Changed: 2020-04-22
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2004-D-0182">FDA-2004-D-0182</a>

## Related Documents

- [180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day](https://www.globalkeysolutions.net/guidances/guidance-document/180-day-exclusivity-when-multiple-andas-are-submitted-on-the-same-day/26a43ba4-c062-4358-b394-9623fa7f9f78)
- [Nonclinical Safety Evaluation of Pediatric Drug Products](https://www.globalkeysolutions.net/guidances/guidance-document/nonclinical-safety-evaluation-of-pediatric-drug-products/a5729b5c-7a6e-40c1-861d-e8acf3cd178a)
- [User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR](https://www.globalkeysolutions.net/guidances/guidance-document/user-fee-waivers-for-fdc-and-co-packaged-hiv-drugs-for-pepfar/13c7af5f-84b1-4023-80d0-9ff6cb3357dc)