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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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| Drug Master Files for Bulk Antibiotic Drug Substances |
| Origin/Publisher: | FDA Office of Enforcement, HFC-200, 5600 Fishers Lane, Rockville, MD 20857, http://www.fda.gov/cder/guidance/index.htm |
| Content: | This FDA Guideline deals specifically with Drug Master Files for antibiotics. |
| Document Type: | FDA Guidance for Industry |
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