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The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
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| ANDA's: Impurities in Drug Substances |
| Internet: | http://www.fda.gov/cder/guidance/6422dft.pdf |
| Origin/Publisher: | Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ |
| Content: | This guidance provides recommendations for information in ANDAs and supporting DMFs on the identification and qualification of impurities in drug subtances. |
| Status: | Draft |
| Document Type: | Guidance for Industry |
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